News From Industry Sources
Patients taking Cymbalta(R) experienced reduced chronic low back pain in new study
August 25, 2008
Data from a new study suggest that Cymbalta (duloxetine HCl) 60-120 mg once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) 24-hour average pain score, compared with placebo. Story
Biovail receives Canadian approval for Ralivia(TM) for the treatment of moderately severe pain
August 25, 2008
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Biovail Corporation announced that it has received an expanded indication for once-daily Ralivia (once-daily tramadol) -- to include the treatment of moderately severe pain in addition to moderate pain -- from the Therapeutic Products Directorate (TPD) in Canada. Story
Prolonged release oxycodone/naloxone provides effective pain relief and reduces opioid induced constipation in patients with severe chronic pain
August 20, 2008
Prolonged release oxycodone / naloxone is as effective as oxycodone alone in providing pain relief for patients with moderate to severe chronic pain while reducing the risk of opioid-induced constipation (OIC), according to new phase II and III recent data. Story
Pain Therapeutics and King Pharmaceuticals announce final data of REMOXY phase III study at World Pain Congress in Scotland
August 19, 2008
Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. presented the final data set of a previously announced pivotal Phase III study of REMOXY®, an investigational drug to treat chronic pain. The final data confirm REMOXY provides effective around-the-clock analgesia within a patented formulation designed to resist common methods of misuse and abuse. The Companies believe this Phase III clinical study is the first to show analgesic efficacy of any twice-daily oxycodone formulation over 12 weeks in a large, well-controlled clinical study. Story
St. Jude Medical receives U.S. and European approvals of EonC, the first extended-life primary cell neurostimulator for the treatment of chronic pain
August 13, 2008
The EonC neurostimulator provides a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device. Neurostimulators like EonC are designed to provide SCS therapy to treat complex neuropathic pain of the trunk and limbs or pain from failed back surgeries. Similar in function and appearance to cardiac pacemakers, these devices deliver mild electrical pulses to the spinal cord, interrupting or masking the pain signals’ transmission to the brain. Story
FDA accepts REMOXY new drug application and grants priority review
August, 12, 2008
Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. today announced that the New Drug Application (NDA) for REMOXY(r) was accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA). The FDA typically grants Priority Review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products. The FDA goal for completing review of a drug with Priority Review status is six months from the date the application was submitted. Story
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