~June 2009

Product News and Clinical Trial Results

Lilly resubmits Cymbalta supplemental New Drug Application for chronic pain to U.S. Food and Drug Administration
June 03, 2009 Source: Eli Lilly and Company
Lilly and Company has resubmitted its supplemental New Drug Application for Cymbalta (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration. Lilly's resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgiaStory

Almirall gets FDA approval for migraine drug
June 03, 2009 Source: Almirall
Spanish pharmaceutical firm Almirall syas its Almotriptan migraine drug has gained U.S. Food and Drug Administration approval for adolescents. The drug -- marketed with U.S. partner Johnson & Johnson's Ortho-McNeil Janssen Pharmaceuticals -- was already sold to treat migraines in adults, but is the first of its kind to be approved by the FDA for adolescents. Story

For patients with irritable bowel syndrome (IBS), iPhone to the rescue
June 1, 2009 Source: Behavioral Health Associates of NC, Inc
Behavioral Health Associates of NC, Inc. announces the release for sale of the iPhone symptom tracker application for Irritable Bowel Syndrome. This application helps users keep track of bowel function as well as ten other variables in order to create an accurate picture of IBS symptom experience. Story

MAP Pharmaceuticals Phase 3 trial of LEVADEX migraine product candidate meets all four primary endpoints
May 26, 2009 Source: MAP Pharmaceuticals, Inc
MAP Pharmaceuticals, Inc. announced today that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX(TM) orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing. Story

New Phase 3 study of tapentadol immediate release tablets published in Current Medical Research and Opinion journal
May 26, 2009 Source: Johnson & Johnson Pharmaceutical Research & Development
According to a new Phase 3 clinical study, tapentadol immediate release (IR) tablets provided patients with equivalent efficacy in pain relief following orthopedic surgery and significant reduction in nausea and/or vomiting compared to oxycodone IR. Story

Comfrey root extract ointment relieves back pain fast
May 21, 2009 Source: British Journal Of Sports Medicine
An ointment containing an extract of comfrey root quickly and effectively relieves back pain. Researchers base their findings on 120 people with upper or lower back pain who were treated three times a day for five days with either a dummy ointment or one containing comfrey root extract. Story

Feldenkrais Movement Institute announces simple non-surgical solutions for jaw and facial pain (TMJ)
May 18, 2009 Source: The Feldenkrais Movement Institute
The Feldenkrais Movement Institute announces the release of The Intelligent Body(R) TMJ Program as part of its The Intelligent Body(R) DIY-series of movement reeducation lessons available on CD. The program offers sufferers of jaw pain an inexpensive and effective self-care method to help reduce chronic tension in the jaw, face, neck and upper back. The lessons also reverse long-standing movement habits often responsible for the original TMJ symptoms. Story

UCB's CIMZIA(R) (certolizumab pegol) approved by the U.S. FDA for adult patients suffering from moderate to severe rheumatoid arthritis
May 13, 2009 Source: UCB
UCB announced today that the U.S. Food and Drug Administration approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis . Patients treated with Cimzia, together with methotrexate, experienced rapid and significant improvements in signs and symptoms, physical function and pain as early as week one, and sustained at week 24 and for up to one year. Story

Ferring Pharmaceuticals unveils six-month efficacy data for EUFLEXXA for the treatment of osteoarthritis knee pain
May 13, 2009 Source: Ferring Pharmaceuticals
Ferring Pharmaceuticals recently presented the results of a six-month safety and efficacy study demonstrating that EUFLEXXA (1% sodium hyaluronate) was effective at decreasing the pain of knee osteoarthritis at 26 weeks. EUFLEXXA is a three-injection treatment regimen indicated for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. Story

First treatment for fibromyalgia pain now available in Canada
First treatment for fibromyalgia pain now available in Canada
Pfizer Canada Inc. has announced that LYRICA(R) (pregabalin) is now indicated for the management of pain associated with fibromyalgia, giving the approximately one million Canadians who suffer from this debilitating condition a key component towards managing their disease. Story

BioElectronics completes menstrual pain clinical study
May 12, 2009 Source: BioElectronics Corporation
Based on a recent clinical study, BioElectronics intends to file 510(K) premarket notification for its Allay Therapy. The filing will be for the indication of reducing menstrual pain symptoms with the U.S. Food and Drug Administration. Story

Forest Laboratories, Inc. and Cypress Bioscience, Inc. announce commercial availability of Savella
April 20, 2009 Source: Forest Laboratories, Inc.; Cypress Bioscience, Inc.
Forest Laboratories, Inc. and Cypress Bioscience, Inc. have announced that that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor approved for the management of fibromyalgia, will be shipped to wholesalers on April 24th and will be available at pharmacies beginning on April 28th 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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