News From Industry Sources
Alpharma submits New Drug Application for EMBEDA
February 28, 2008
Alpharma Inc. announced that a New Drug Application (NDA) has been submitted for EMBEDA, a pharmacological abuse-deterrent, extended-release morphine product candidate. Story
Abbott receives FDA approval for HUMIRA (adalimumab) for polyarticular juvenile idiopathic arthritis
February 22, 1008
HUMIRA Is the First Biologic Treatment Approved in Nine Years for to relieve the "The pain and inflammation Juvenile Idiopathic Arthritis. The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. HUMIRA is the first biologic treatment to receive FDA approval for this condition since 1999, and the first to be administered by injection in these patients once every two weeks. Story
Preliminary clinical study data suggests that Celliant reduces pain
February 21, 2008
Celliant is a specially formulated material designed to enhance oxygen levels in the body, aiding in comfort, healing and overall wellness. Early data analysis from a recent clinical study suggests that the material also has potent pain relief capabilities. Story
Forest and Cypress announce FDA acceptance for review of New Drug Application for milnacipran for the treatment of fibromyalgia
February 21, 2008
The Companies submitted their NDA for milnacipran for the treatment of fibromyalgia syndrome based on results from a composite responder analysis requiring that each patient experienced concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function. Story
Data from two pivotal trials of AMRIX, a new once-daily extended-release muscle relaxant
February 14, 2008
Clinical trials showed that AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), a new once-daily extended-release skeletal muscle relaxant, was superior to placebo. AMRIX had similar efficacy to cyclobenzaprine immediate-release (CIR) taken three times a day in alleviating acute muscle spasm associated with lower back and neck pain. In addition, less daytime drowsiness was observed with AMRIX compared to
CIR Story
Horizon Therapeutics completes enrollment in phase 3 trials for lead product candidate HZT-501
February 11, 2008
Horizon Therapeutics, Inc announced that it is closing enrollment in its two phase 3 trials HZ-CA-301 and HZ-CA-303 for its lead product candidate HZT-501, an investigational prescription NSAID (non-steroidal anti-inflammatory drug) designed to be "GI-friendly". Story
HealthSonix gives green light for production of the enSonix medical device
February 11, 2008
HealthSonix Inc today announced that it is has approved the final sample of its second generation enSonix medical device. The enSonix personal treatment device has been registered and cleared with the United States, Food and Drug Administration and has been indicated for pain reduction and muscle relaxation. Story
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