~May 2009

Product News and Clinical Trial Results

Phase 3 clinical study of RELISTOR presented at American Pain Society meeting showed positive activity for the treatment of opioid-induced constipation in chronic, non-cancer pain patients
May 7, 2009 Source: Progenics Pharmaceuticals
Wyeth Pharmaceuticals and Progenics Pharmaceuticals, Inc. have announced results from the one-month, double-blind portion of a phase 3 trial of RELISTOR® (methylnaltrexone bromide) subcutaneous injection. The data presented from this 460-patient clinical study which evaluated RELISTOR for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain showed that significantly more patients treated with RELISTOR had laxation within four hours after the first dose compared with placebo. Story

White paper examines the importance of on-dose technologies in the fight against illegal diversion of opioid medications
May 6, 2009 Source: NanoGuardian
Dr. John Glover published a white paper extolling necessary requirements of the Food and Drug Administration (FDA)-proposed Risk Evaluation and Mitigation Strategies (REMS) for opioid products, commonly referred to as pain medications. The white paper, entitled "The Importance of On-Dose Technologies in the Fight Against Misuse, Abuse and Illegal Diversion of Opioids," addresses the pressing need for on-dose technologies in the battle against illicit diversion and the intentional misuse and abuse of opioid medications. Story

Expert panel finds that SOAPP® is likely to be helpful for assessing opioid addiction risk
May 6, 2009 Source: Inflexxion, Inc
Inflexxion, Inc. is pleased to announce that its Screener and Opioid Assessment for Patients with Pain (SOAPP) has been identified by an expert panel as likely to be helpful for assessing the risk of opioid addiction in patients with chronic non-cancer pain. The SOAPP tool is available for download at no cost through Inflexxion's PainEDU website (www.PainEDU.org), along with a clinician tutorial that includes video case examples. Story

Curamin voted best new natural remedy in the country
May 5, 2009 Source: EuroPharma
Curamin, an all-natural supplement that enhances the body's natural defense mechanism for the relief of pain, is slated to receive a first place Vity Award from Vitamin Retailer magazine. The annual Vity Awards honor the industry's best-selling products based on a nationwide survey of health food stores.Story

Experts recommend cherries for pain relief from arthritis
May 04, 2009 Source: The Cherry Marketing Institute
For instance, many sufferers have sworn for years that cherry juice minimized arthritis symptoms. Now, the anecdotal claims are supported by scientific evidence showing that tart cherries (available dried, frozen or in juice form) may help play a role in reducing the pain of arthritis. Scientists believe it's the anthocyanins - also responsible for cherries' vibrant red color - that are responsible for this anti-inflammatory benefit. Story

Excess oral doses of Acurox® tablets are disliked by subjects with a history of opioid abuse
May 01, 2009 Source: King Pharmaceuticals
Results from an oral abuse liability study demonstrate that Acurox® Tablets (oxycodone HCl/niacin) are disliked among people with a history of opioid abuse compared to oxycodone HC1 tablets alone, when excess doses are swallowed. The niacin is well tolerated at the recommended two-tablet dose, however, as doses are escalated, niacin induces increasingly unpleasant, dysphoric, yet temporary, effects. Story

Lyrica significantly reduced pain and improved other symptoms of post-traumatic peripheral nerve pain, new data show
April 30, 2009 Source: Pfizer Inc
New data shows that patients suffering from post-traumatic peripheral nerve pain treated with Lyrica® (pregabalin) capsules CV experienced significantly reduced pain compared to those taking placebo. The data also showed that patients treated with Lyrica reported less pain interference with sleep and were significantly more likely to report feeling better overall at the end of the study compared with placebo. Story

FDA approves DYSPORT(TM) for therapeutic and aesthetic uses
April 30, 2009 Source: Source: Medicis Pharmaceutical Corporation
Medicis and Ipsen announced the U.S. Food and Drug Administration's approval of the Biologics License Application for DYSPORT(TM) (abobotulinumtoxinA), The approval includes two separate indications, the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Story

OncoGenex receives confirmation from FDA on the design of a second phase 3 trial evaluating OGX-011 for the treatment of advanced prostate cancer
April 28, 2009 Source: OncoGenex Pharmaceuticals, Inc
OncoGenex Pharmaceuticals, Inc. announced today that the company has reached an agreement with the U.S. Food and Drug Administration on the design of a second Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer (CRPC), via the Special Protocol Assessment (SPA) process. The FDA has agreed that the design and planned analysis of our Phase 3 trial featuring durable pain palliation as the primary endpoint adequately addresses the objectives necessary to support a regulatory submission. Story

QRxPharma successfully completes comparative study for Dual-Opioid(TM) pain therapy
April 20, 2009 Source: QRxPharma
QRxPharma Limited announced today the successful completion of a Phase 3 program pilot study comparing the efficacy and safety profile of MoxDuo(TM) IR against component doses of morphine and oxycodone. Results demonstrated that MoxDuo(TM) IR reduces pain significantly more than its component doses; further, when compared to equianalgesic doses of morphine and oxycodone, MoxDuo(TM) IR produced fewer and less intense side effects. Story

Chattanooga division of DJO receives FDA market clearance for Shortwave Diathermy for pain relief, joint contractures, and chronic inflammatory conditions
April 16, 2009 Source: DJO Inc.
DJO Incorporated has received 510-K clearance from the U.S. FDA to market and sell the Intelect® SWD Shortwave Diathermy device in the United States. Shortwave Diathermy is a clinical treatment modality that provides a superior form of deep tissue heating. Indications for use include: pain relief, reduction of muscle spasm, decreasing joint stiffness, contractures, increased blood flow, chronic inflammatory conditions, bursitis, tenosynovitis, synovitis and chronic inflammatory pelvic disease. Story

BIOLASE announces FDA 510(K) clearance of its ezlaseTM diode laser for pain therapy & relief
April 16, 2009 Source: Biolase Technology
The FDA has given clearance for the ezlase for the following indications: "The ezlase™ diode system emits energy in the near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle." Story


American Academy of Pain Management is the nation's largest interdisciplinary/integrative organization serving clinicians who treat people with pain through education, setting standards of care, and advocacy.
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