Fibromyalgia Circle of Care Initiative

FROM THE DESK OF JEANNE HAMBLETON UK NFA LEADER AGAINST PAIN

October 25, 2008 08:00 AM Eastern Daylight Time
Johns Hopkins and National Fibromyalgia Association Launch Fibromyalgia Educational Initiative to Bridge Chasm in Diagnosis and Care

Collaborative Program Shifts Paradigm with Evidence-Based Platform to Educate Providers on Fibromyalgia Management

SAN FRANCISCO–(BUSINESS WIRE)–The Johns Hopkins University School of Medicine, The Institute for Johns Hopkins Nursing and the National Fibromyalgia Association announced today the launch of the Fibromyalgia Circle of Care Initiative at the ACR/ARHP Annual Scientific Meeting, October 24-29, 2008 in San Francisco. The outcomes-based educational initiative will educate providers about the disease state and the latest therapeutic options; thus, driving accurate and early diagnosis of fibromyalgia for the ten million U.S. citizens impacted by this disorder.

The multi-interventional series of educational activities is open to primary care physicians (PCPs), rheumatologists, psychiatrists, pain management specialists, nurses (RNs), nurse practitioners (NPs) and physician assistants (PAs). The program is designed to educate providers on disease state awareness, diagnosis, impact of early diagnosis and referral, and multidisciplinary care. Additionally, the initiative will share the latest therapeutic options and strategies, as well as review clinical trials that assess newer therapies for fibromyalgia.

“Many fibromyalgia patients see an average of four physicians—over a duration of five to eight years after the onset of the disease—before an accurate diagnosis of fibromyalgia is achieved. This represents five to eight years of underdiagnosis, misdiagnosis and inappropriate treatment of the patient,” said Victor Marrow, Ph.D., Executive Director, Office of Funded Programs/CME Johns Hopkins School of Medicine. “The Fibromyalgia Circle of Care Initiative will result in improved patient care by minimizing the lack of awareness among physicians which has been responsible for the inability or reluctance to accurately diagnose, contributing to the fragmentation of care.”

The Johns Hopkins University School of Medicine, The Institute for Johns Hopkins Nursing and the National Fibromyalgia Association are collaborating on this unique program to improve fibromyalgia patient outcomes. The integrated educational activities will deliver:

Practical and interactive case-related content
Summaries of clinical data and recommendations on how to implement management strategies into the provider’s practice
Updates on clinical practice guidelines and recommendations
Evidence-based outcomes
Patient communication content and materials
Treatment adherence and compliance strategies
“The Fibromyalgia Circle of Care Initiative is unique in its collaboration among healthcare organizations and leaders to raise awareness of the disease state through an interactive program that effectively drives provider participation and implementation of evidence-based lessons within their own practice,” said Lynne Matallana, President and Founder, National Fibromyalgia Association. “After completion of this program, participants will be fully prepared to use the tools and lessons learned to positively and tangibly impact the quality of life of these patients.”

With fibromyalgia affecting up to ten million people in the United States, or up to six percent of patients seen in general medical practices, the impact to the U.S. economy is significant. According to a 2003 study by I. Jon Russell, et al., healthcare costs range from $12-$14 billion per year and account for a loss of one to two percent of the nation’s overall productivity. The study also found that total annual costs for fibromyalgia claimants were more than twice as high as the costs for the typical insurance beneficiary. Furthermore, the prevalence of disability among employees with fibromyalgia was twice as high as compared to all employees. Lastly, for every dollar spent on fibromyalgia-specific claims, employers spent approximately $50-$100 on additional direct and indirect costs.

For more information or to register to participate in the Fibromyalgia Circle of Care Initiative, e-mail info@circleofcare.md.

ABOUT THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE

In July 2008, U.S. News & World Report ranked the Johns Hopkins Hospital #1 among American hospitals for the 18th consecutive year. In 2006, the Johns Hopkins Office of CME received “Accreditation with Commendation” for six years, the highest ranking issued by the ACCME. Hopkins CME has been recognized as a center for “Best Practices” and as a resource to ACCME-accredited providers. For more information, please visit http://www.hopkinscme.edu or contact Victor Marrow, Ph.D., Executive Director, CME’s Office of Funded Programs at vmarrow@jhmi.edu.

ABOUT THE INSTITUTE FOR JOHNS HOPKINS NURSING

The Institute for Johns Hopkins Nursing designs and delivers leading-edge continuing education for nurses. The Institute accesses the expertise of faculty and nurses from both the Johns Hopkins University School of Nursing and Johns Hopkins Hospital, including over 2,500 highly skilled clinicians in 10 clinical and countless subspecialty areas who are also world-renowned researchers and educators. For more information please visit http://www.ijhn.jhmi.edu.

ABOUT THE NATIONAL FIBROMYALGIA ASSOCIATION

The National Fibromyalgia Association (NFA) is a nonprofit 501(c)(3) organization whose mission is to develop and execute programs dedicated to improving the quality of life for people affected by fibromyalgia. The NFA publishes a quarterly magazine, Fibromyalgia AWARE, and hosts an award-winning website at http://www.FMaware.org.

Contacts
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jshulman@ACmarketingPR.com

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JRRD releases single-topic issue on pain and pain management

Effects of depression and pain severity on satisfaction in medical outpatients: Analysis of the Medical Outcomes Study, pg. 143

Patient satisfaction is a critical measure of healthcare quality. We performed this study to see how depression and pain severity affected patient satisfaction in medical outpatients. We analyzed data from the Medical Outcomes Study and found that pain was very common and patients with depression and pain were much more likely to be dissatisfied with their healthcare. These findings may also have care-delivery implications, should dissatisfaction indicate poorer quality of care. Further study is needed to determine the reasons for dissatisfaction with care in patients with depression and pain.

Veterans seeking treatment for posttraumatic stress disorder: “What about comorbid chronic pain” pg. 153

In veterans who were being treated for posttraumatic stress disorder (PTSD), many (66%) were also diagnosed with chronic pain problems by their doctors. This is the first study to show that people with PTSD have pain-related conditions according to their doctors. The veterans who told their primary care doctor that they had pain before PTSD treatment said that their pain was less during and after the PTSD treatment. However, this finding was based on a review of charts, so other reasons could also explain the improvement in pain symptoms. More research about treatment for veterans with pain and PTSD is needed.

Prevalence and correlates of posttraumatic stress disorder and chronic severe pain in psychiatric outpatients, pg. 167

This study contributes to the growing literature on the co-occurrence of posttraumatic stress disorder (PTSD) and chronic severe pain. We found moderate rates of PTSD (46%) and chronic severe pain (40%) in a sample of psychiatric outpatients. In addition, 24% of the sample had both disorders. We found that persons with both disorders were significantly different from those with neither disorder on all variables and that they had greater physical and psychosocial stressors. In addition, persons with either PTSD or chronic severe pain alone were more likely to have a chronic medical condition, higher ratings of psychiatric distress, and more stressful life events than those with neither disorder. Mental health treatment providers should routinely assess and develop management strategies for these two disorders in psychiatric outpatients.

Pain and combat injuries in soldiers returning from Operations Enduring Freedom and Iraqi Freedom: Implications for research and practice, pg. 179

Operations Enduring Freedom and Iraqi Freedom have resulted in a growing number of seriously injured soldiers evacuated to the United States for medical care. Trauma-related pain is almost always present among these war-injured soldiers. Several military and Department of Veterans Affairs programs have been implemented to improve pain care. We describe several of these new approaches. We also present data on the soldiers treated, the services provided, and the effects of treatment. Finally, we identify some of the challenges emerging from work with this population and recommend future research and practice priorities.

Efficacy of selected complementary and alternative medicine interventions for chronic pain, pg. 195

We review published research on commonly used complementary and alternative medicine (CAM) approaches to treating chronic pain. Our findings show that CAM therapies, as a group, have a mixed track record of efficacy. The modalities that have the best track records for pain management include biofeedback, hypnosis, and massage (mostly for low back pain and shoulder pain). In selecting a CAM modality, practitioners must weigh the pros and cons and tailor the interventions to the needs of patients with chronic pain. Other issues relevant to practitioners include additional time and energy investments, need for specialized training to administer the modality, side effects or potential toxic effects, safety in combining CAM and other modalities, likely acceptance by clients and the public, and ease of incorporation into traditional pain management practices.

Preliminary evaluation of reliability and criterion validity of Actiwatch-Score, pg. 223

Restoration of normal physical activity is a primary objective of most chronic pain rehabilitative interventions, yet few clinically practical objective measures of activation exist. We evaluated the measurement properties of the Actiwatch-Score (AW-S). We conducted separate trials to examine concordance between units when worn concurrently at the same and different body sites and to compare the AW-S with a validated optical three-dimensional motion-tracking system. The data indicate that the AW-S has excellent interunit reliability and good criterion validity, but its intersite reliability varies with activity type. These results suggest that this device, and those like it, warrants further investigation and is likely to yield valuable data regarding the optimal application of this technology.

A closer look at pain and hepatitis C: Preliminary data from a veteran population, pg. 231

Many veterans who have hepatitis C also experience pain. Researchers are learning how to care for patients who experience hepatitis C and pain. They are also learning how hepatitis C and pain can affect patients’ lives. We review research on the relationship between hepatitis C and pain. We also present findings from a survey given to patients at two Department of Veterans Affairs hospitals. Finally, we suggest how physicians and mental health providers can best care for patients with hepatitis C and pain.

Overview of the relationship between pain and obesity: “What do we know. Where do we go next” pg. 245

Many veterans who struggle with being overweight also experience pain. Researchers are beginning to learn more about how being overweight or obese can affect several health conditions, including pain. We reviewed recent research examining the relationship between pain and overweight/obesity to promote understanding of when, why, and how these conditions occur together. Additionally, we suggest ways researchers can better study the problem of weight and pain to help veterans who experience both.

Medical residents’ beliefs and concerns about using opioids to treat chronic cancer and noncancer pain: A pilot study, pg. 263

Chronic pain from conditions such as arthritis or nerve injuries may be disabling and poorly controlled with aspirin, acetaminophen (Tylenol), or ibuprofen (Advil). In selected cases, opioid analgesics (e.g., morphine), combined with other treatments, can safely and more effectively relieve pain and improve function. We surveyed less experienced doctors and found that they had many fears, concerns, and negative beliefs toward using opioids to treat noncancer pain such as low back pain. If other doctors share these feelings, finding ways to increase their comfort by identifying and treating patients who might safely benefit from opioids to reduce their suffering and disability is important.

Persistent benefits of rehabilitation on pain and life quality for nonambulatory patients with spinal epidural metastasis, pg. 271

We evaluated the long-term effects of a 2-week course of rehabilitation on people with paraplegia caused by cancer compressing the spinal cord. Twelve patients received rehabilitation that focused on transfers, skin care, bladder and bowel management, nutrition, and incentive spirometry. We compared these study patients with a historical control group of 30 patients who had paraplegia from cancer but did not receive rehabilitation. Subjects were followed until death. The study patients had less pain and depression and more satisfaction with life; these benefits persisted for the remainder of their lives. In contrast, the control patients had worsening pain levels, declining satisfaction with life, and higher pain medication use for the remainder of their lives. While our study suggests that rehabilitation benefits people with cancer-related spinal cord injury, it needs to be supported by a randomized study.

Pain and palliative medicine, pg. 279

Pain control is an important part of medical care for patients with advanced illnesses. We summarize available information on pain in different patient groups near the end of life and on developments using behavioral and physical therapy methods to treat pain. Clinical trials to treat pain in patients within healthcare systems are the next topic, followed by ideas on how information technology and clinical databases can be used to guide future patient care. Finally, we present perspectives on how pain control can be studied and further improved within healthcare systems.

Moving to new settings: Pilot study of families’ perceptions of professional caregivers’ pain management in persons with dementia, pg. 295

Pain in persons with severe dementia is often not recognized or treated because these persons cannot communicate their needs. Family caregivers are in the best position to provide information to hospital care personnel about the patients’ needs, including pain. Little research has evaluated the role of the family caregiver when patients move between care facilities. This study describes family caregivers’ experiences when their family members with dementia were admitted to unfamiliar care sites and provides the caregivers’ recommended changes to healthcare settings. This article is relevant to family members and healthcare professionals who care for persons with severe dementia.

Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents, pg. 305

More than 80% of nursing home residents have chronic pain, and of these, many are not getting adequate treatment. Good pain treatment begins with knowing how severe the pain is. Several different pain-intensity tools are available: one uses a number (0–10) scale, another uses words, and a third shows pictures of people in pain. We asked nursing home residents to rate their pain using all three scales. We wanted to know how the pain reported on one scale translated onto another scale. The 42,000 veterans who live in nursing homes and their families will benefit from this study.

Cognitive impairment and pain management: Review of issues and challenges, pg. 315

Research shows that pain is often not recognized in persons with communication problems related to brain disease. Older persons with dementia experience memory loss, and seriously ill and dying patients experience confusion. Treating pain will increase the comfort of all these persons. In this article, we review the types of problems that affect the brain and interfere with pain management, how pain is measured, what pain management approaches help, and future research needs. Those who care for adults with brain-related disease will find this article relevant.

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Now Available Online and in Print–http://www.rehab.research.va.gov

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Responder criteria for operant and cognitive-behavioral treatment of fibromyalgia syndrome.

1: Arthritis Rheum. 2007 May 25;57(5):830-836 [Epub ahead of print]

Thieme K, Turk DC, Flor H.

University of Heidelberg, Mannheim, Germany.

OBJECTIVE: To predict the effects of cognitive-behavioral therapy (CBT) and operant-behavioral therapy (OBT) in fibromyalgia syndrome (FMS).

METHODS: A total of 125 patients who fulfilled the American College of Rheumatology FMS criteria were randomly assigned to CBT (n = 42), OBT (n = 43), or attention placebo (AP; n = 40). The pretreatment to 12-month followup reliability change index was used to determine clinically meaningful changes in pain intensity and physical impairment. Multinominal logistic regression analyses were used to determine the predictors of improvement in pain intensity and physical impairment for the entire sample. Analyses of variance were computed to compare the characteristics of responders and nonresponders in each of the 3 interventions.

RESULTS: At the 12-month followup, 53.5%, 45.2%, and 5% of patients in the OBT, CBT, and AP groups, respectively, reported clinically meaningful improvements in pain intensity. Similarly, 58.1%, 38.1%, and 7.5% of patients treated with OBT, CBT, and AP, respectively, reported clinically significant improvements in physical impairment. Prior to treatment, the OBT physical impairment responders displayed significantly more pain behaviors, physical impairment, physician visits, solicitous spouse behaviors, and level of catastrophizing compared with nonresponders. The CBT physical impairment responders, compared with nonresponders, reported higher levels of affective distress, lower coping, less solicitous spouse behavior, and lower pain behaviors.

CONCLUSION: The results of this study suggest that pretreatment patient characteristics are important predictors of treatment response and may serve as a basis for matching treatments to patient characteristics. Prospective outcome studies are needed to confirm whether the tailoring of treatment actually leads to better outcomes for patients with FMS.

PMID: 17530683 [PubMed - as supplied by publisher]

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Imaging pain of fibromyalgia.

1: Curr Pain Headache Rep. 2007 Jun;11(3):190-200.

Cook DB, Stegner AJ, McLoughlin MJ.
William S.

Middleton Memorial Veterans Hospital, Madison, WI 53706; Department of Kinesiology, University of Wisconsin, Madison, WI 53706, USA. dcook@education.wisc.edu.

Brain imaging studies have provided objective evidence of abnormal central regulation of pain in fibromyalgia (FM). Resting brain blood flow studies have reported mixed findings for several brain regions, whereas decreased thalamic blood flow has been noted by several investigators. Studies examining the function of the nociceptive system in FM have reported augmented brain responses to both painful and non-painful stimuli that may be influenced by psychologic dispositions such as depressed mood and catastrophizing. Treatment approaches are beginning to demonstrate the potential for brain imaging to improve our understanding of pain-alleviating mechanisms. Data from other chronic conditions suggest that idiopathic pain may be maintained by similar central abnormalities as in FM, whereas chronic pain conditions with a known nociceptive source may not be. Future neuroimaging research in FM is clearly warranted and should continue to improve our understanding of factors involved in pain maintenance and symptom exacerbation.

PMID: 17504646 [PubMed - in process]

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Novel pharmacotherapy for fibromyalgia.

1: Expert Opin Investig Drugs. 2007 Jun;16(6):829-41.

Wood PB, Holman AJ, Jones KD.

Louisiana State University Health Sciences Center–Shreveport, Department of Family Medicine, Shreveport, LA 71130, USA. pwood@lsuhsc.edu

Fibromyalgia is a common disorder that is characterized by chronic widespread pain, tenderness to light palpation, fatigue and sleep disturbances. The present lack of a well-accepted model of the disorder has hampered progress towards adequate treatment. A review of potential models to explain the pathophysiology underlying its primary symptom (i.e., chronic widespread pain) lends insight on the therapeutic potential of novel therapies. Following this, a mechanistic evaluation of those medications that are under consideration for the treatment of the disorder is offered. Adequate treatment will be likely to involve the identification of biologic subgroups within the greater fibromyalgia construct. Key insights from basic research are the basis for increased optimism for effective relief among patients and clinicians.

PMID: 17501695 [PubMed - in process]

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FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

FOR IMMEDIATE RELEASE
P07-85
May 10, 2007
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA

Company Misrepresented Prescription Pain Reliever to Health Care Professionals
The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.

An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing “fewer peaks and valleys than with immediate-release oxycodone,” and by representing that “…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug.”

“FDA will not tolerate practices that falsely promote drug products and place consumers at health risk,” said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. “We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars.”

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States.

In addition, Purdue’s current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications.

This case was prosecuted by the U. S. Attorney’s Office for the Western District of Virginia and investigated by FDA’s Office of Criminal Investigations; the Internal Revenue Service’s Criminal Investigations Division; the U.S. Department of Health and Human Services’ Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation.

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BEMA Fentanyl demonstrates substantial transmucosal delivery

Contact: Bill Douglass
bill@investorrelationsgroup.com
BioDelivery Sciences

Findings form a part of pending NDA for the treatment of breakthrough cancer pain findings form a part of pending NDA for the treatment of breakthrough cancer pain
Morrisville, North Carolina, May 7, 2007 — BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced the results of a 12 subject, crossover study comparing the absorption of fentanyl from both single and multiple BEMA™ Fentanyl discs, as well as oral and intravenous doses of fentanyl. The data demonstrates that the absolute bioavailability (i.e. the total amount absorbed from the delivery system) of fentanyl through the BEMA disc was more than 70%, with 50% absorbed through the buccal mucosa (the inner lining of the cheek). The study further demonstrates that equal doses administered as either a single disc or multiple discs produced nearly identical plasma concentrations (i.e. two 200 mcg discs provided nearly equivalent plasma concentrations as one 400 mcg disc, etc.)

These findings follow the Company’s April 25, 2007 announcement of statistically significant results with BEMA Fentanyl in treating cancer patients with breakthrough pain in the company’s Phase III efficacy clinical trial. BDSI plans to include today’s study results, the efficacy trial results and other materials in its planned submission of a New Drug Application (NDA) to the FDA for BEMA Fentanyl. The NDA submission is expected during third quarter of 2007.

BEMA Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal membranes. Upon administration, BEMA Fentanyl is designed to deliver a rapid, reliable dose of drug across mucous membranes. BEMA Fentanyl is being developed for the treatment of “breakthrough” cancer pain (i.e. episodes of severe pain which “break through” the medication already in use to control the persistent pain).

Dr. Andrew Finn, Executive Vice President of Product Development for BDSI, stated “The results of this study confirm, and are an expansion of, the information obtained in our 2006 pharmacokinetic study which demonstrated that fentanyl absorption from the BEMA delivery system was better than that seen with Actiq®. This study showed that the absolute bioavailability from BEMA Fentanyl and the amount of fentanyl absorbed directly through the buccal mucosa was substantial (70% and 50%, respectively). Although the study announced today was not a direct comparative study, our bioavailability results are greater than those previously reported with Actiq® (50% and 22%), and similar to those previously reported with Fentora™ (65% and 48%). Given the linear increase in plasma concentrations with increases in dose, and the nearly identical plasma concentrations when a dose is administered as a single disc or with multiple discs, we believe doctors will have the needed flexibility in titrating the dose of BEMA Fentanyl to meet the changing analgesic requirements of patients with breakthrough cancer pain.”

Actiq®, marketed by Cephalon, Inc., is the leading fentanyl product for the treatment of breakthrough cancer pain in the U.S. market. Cephalon introduced a second fast dissolving fentanyl product, Fentora™, in 2006. The reported combined sales of these products in 2006 were $659 million.

Dr. Mark Sirgo, President and CEO of BDSI, stated “These results continue to demonstrate the consistency in the performance of the BEMA delivery system. The principal purpose of a transmucosal delivery system is to have the majority of the drug absorbed through that membrane, thereby allowing for a rapid onset of action while minimizing the amount of drug that is swallowed. Today’s results show that the BEMA technology and our BEMA Fentanyl product specifically meet this principle. These results, when combined with the recent announcement of achieving our primary efficacy endpoint in our breakthrough cancer pain Phase III efficacy study, give us continued confidence that the commercial value for BEMA Fentanyl remains on target with our expectations. In addition, we believe these continued positive findings with our BEMA technology lend support to the continued development of other products in the technology, including our next pain product in development, BEMA LA.”

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About BEMA™ Fentanyl

BEMA™ Fentanyl is BDSI’s lead product in development. BDSI believes there is a clear need and growing market for additional agents in alternative dosage forms to provide rapid pain relief. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The transmucosal form of fentanyl is a powerful narcotic used to treat breakthrough cancer pain. BDSI believes that fentanyl applied with its BEMA™ disc technology has the potential to meet the market need for new narcotics and, BDSI believes, will be well suited for breakthrough cancer pain in opioid-tolerant patients.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner and commercialize, clinically-significant new products using proven therapeutics. BDSI’s pain franchise currently consists of two products in development utilizing the company’s patented BEMA™ oral adhesive disc technology: BEMA™ Fentanyl, a treatment for “breakthrough” cancer pain, and BEMA™ LA, a second analgesic with a target indication of the treatment of moderate to severe pain. The company is also working with both its BEMA™ technology and its patented Bioral® nanocochleate technology on products targeted at other acute treatment opportunities such as insomnia, nausea and vomiting, and infections. The company’s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit http://www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release and the statements of representatives of BioDelivery Sciences International, Inc. (the “Company”) related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects”, “may”, “could”, “would”, “should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, the application of funds, or the timing for completion and results of scheduled or additional clinical trials and FDA review of the Company’s formulations and products, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). Peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.

Contact:
Investor Relations Group
Investor Relations:
James Carbonara, 212-825-3210

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Arthritis pain, the brain and the role of emotions

Contact: Amy Molnar
amolnar@wiley.com
John Wiley & Sons, Inc.

Arthritis pain is processed in brain areas concerned with emotions and fear, finds study, indicating target for pain-relieving therapies
How does the brain process the experience of pain? Thanks to advances in neuroimaging, we now know the answer lies in a network of brain structures called the pain matrix. This matrix contains two parallel systems. The medial pain system processes the emotional aspects of pain, including fear and stress, while the lateral system processes the physical sensations—pain’s intensity, location, and duration.

Marked by morning stiffness, joint aches, and flare-ups, the pain of arthritis tends to be acute and recurrent, in contrast to many chronic pain conditions. Arthritis pain therefore makes an ideal model for comparing common clinical pain with experimental pain. Inspired by this observation, researchers at University of Manchester Rheumatic Diseases Centre in the United Kingdom conducted the first study to compare directly the brain areas involved in processing arthritis pain and experimental pain in a group of patients with osteoarthritis (OA). Their results, published in the April 2007 issue of Arthritis & Rheumatism (http://www.interscience.wiley.com/journal/arthritis), shed light on the role of emotions in how patients feel arthritis pain.

The study focused on 12 patients with knee OA—6 women and 6 men, with a mean age of 52 years. All subjects underwent positron emission tomography (PET), to measure and map 18F-fluorodeoxyglucose (FDG) uptake in the brain as an indicator of brain activity. PET scans were performed during three different pain conditions: arthritic knee pain; experimental pain, achieved by heat application; and pain-free. The brain responses to each pain state were then rigorously examined and statistically evaluated and compared for significant differences.

In all OA subjects, both pain conditions activated the entire pain matrix. However, during arthritic pain, activity was increased within the medial pain system of the brain, including most of the cingulate cortex, the thalamus, and the amygdala. This suggests that, for these patients, arthritis pain has more emotional impact—and perhaps stronger associations with fear and distress—than experimental pain. Arthritis pain also prompted heightened activation of the prefrontal cortex and the inferior posterior parietal cortex, areas of the brain instrumental in the supervision of attention. Their activation while suffering arthritis pain may reflect the patients’ concentration on coping strategies.

“The present study demonstrates the importance of the medial pain system during the experience of arthritic pain and suggests that it is a likely target for both pharmacologic and nonpharmacologic interventions,” notes its leading author, Prof. A.K.P. Jones. “Considering the recent concerns about the long-term safety of cyclo-oxygenase inhibitors, we hope that our current findings will stimulate partnerships between academia and the pharmacological industry to develop a new class of analgesics for arthritic pain that specifically target the medial pain system.”

As Prof. Jones acknowledges, the study’s main limitation is its small number of subjects. Larger studies of the relationship between arthritis pain and the medial pain system are critical, particularly for exploring the effect of variables from depression and anxiety to guided imagery, meditation, and other mind-based pain management techniques. “Researchers should be moving toward more naturalistic studies in patients,” Prof. Jones suggests, “in order to fully understand the perception of different types of clinical pain.”
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Article: “Arthritic Pain Is Processed in Brain Areas Concern With Emotions and Fear,” B. Kulkarni, D.E. Bentley, R. Elliott, P.J. Julyan, E. Boger, A. Watson, Y. Boyle, W. El-Deredy, and A.K.P. Jones, Arthritis & Rheumatism, April 2007; (DOI: 10.1002/art.22460).

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Altered cortical excitability in subjectively electrosensitive patients: Results of a pilot study.

1: J Psychosom Res. 2007 Mar;62(3):283-8.

Landgrebe M, Hauser S, Langguth B, Frick U, Hajak G, Eichhammer P.

Department of Psychiatry, Psychosomatics, and Psychotherapy, University of Regensburg, Regensburg, Germany.

OBJECTIVE: Hypersensitivity to electromagnetic fields is frequently claimed to be linked to a variety of unspecific somatic and/or neuropsychological complaints. Whereas provocation studies often failed to demonstrate a causal relationship between electromagnetic field exposure and symptom formation, neurophysiological examinations highlight baseline deviations in people claiming to be electrosensitive. METHODS: To elucidate a potential role of dysfunctional cortical regulations in mediating hypersensitivity to electromagnetic fields, cortical excitability parameters were measured by transcranial magnetic stimulation in subjectively electrosensitive patients (n=23) and two control groups (n=49) differing in their level of unspecific health complaints. RESULTS: Electrosensitive patients showed reduced intracortical facilitation as compared to both control groups, while motor thresholds and intracortical inhibition were unaffected. CONCLUSIONS: This pilot study gives additional evidence that altered central nervous system function may account for symptom manifestation in subjectively electrosensitive patients as has been postulated for several chronic multisymptom illnesses sharing a similar clustering of symptoms.

PMID: 17324677 [PubMed - in process]

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Long-term opioid contract use for chronic pain management in primary care practice. A five year experience.

1: J Gen Intern Med. 2007 Apr;22(4):485-90.

Hariharan J, Lamb GC, Neuner JM.
Division of General Internal Medicine, Medical College of Wisconsin, Froedtert East Clinic Bldg., Suite E4200, 9200 West Wisconsin Avenue, Milwaukee, WI, 53226, USA, jharihar@mcw.edu.

BACKGROUND: The use of opioid medications to manage chronic pain is complex and challenging, especially in primary care settings. Medication contracts are increasingly being used to monitor patient adherence, but little is known about the long-term outcomes of such contracts. OBJECTIVE: To describe the long-term outcomes of a medication contract agreement for patients receiving opioid medications in a primary care setting. DESIGN: Retrospective cohort study. SUBJECTS: All patients placed on a contract for opioid medication between 1998 and 2003 in an academic General Internal Medicine teaching clinic. MEASUREMENTS: Demographics, diagnoses, opiates prescribed, urine drug screens, and reasons for contract cancellation were recorded. The association of physician contract cancellation with patient factors and medication types were examined using the Chi-square test and multivariate logistic regression. RESULTS: A total of 330 patients constituting 4% of the clinic population were placed on contracts during the study period. Seventy percent were on indigent care programs. The majority had low back pain (38%) or fibromyalgia (23%). Contracts were discontinued in 37%. Only 17% were cancelled for substance abuse and noncompliance. Twenty percent discontinued contract voluntarily. Urine toxicology screens were obtained in 42% of patients of whom 38% were positive for illicit substances. CONCLUSIONS: Over 60% of patients adhered to the contract agreement for opioids with a median follow-up of 22.5 months. Our experience provides insight into establishing a systematic approach to opioid administration and monitoring in primary care practices. A more structured drug testing strategy is needed to identify nonadherent patients.

PMID: 17372797 [PubMed - in process]

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