FDA accepts Labopharm’s NDA for formulation of trazodone
With one in every 20,000 eggs contaminated with Salmonella bacteria, drinking homemade eggnog can be something of a gamble. But an experiment designed to test whether the alcohol in spiked eggnog can kill the deadly bugs suggests that, in general, few bacteria survive in a mixture containing both raw eggs and 20 percent rum and
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Labopharm Inc. has announced that its New Drug Application (NDA) for the Company’s novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA).
The action date under the Prescription Drug User Fee Act (PDUFA) is July 18, 2009.
Labopharm’s NDA for its novel trazodone formulation is based on data from five pivotal pharmacokinetic studies and the positive results from its North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients. The Agency advised the Company that one positive Phase III study is required for the formulation to be approved.
One-half of patients being treated with antidepressants discontinue therapy within a year for reasons related to efficacy and/or tolerability, including delayed onset of therapeutic response, insomnia or sleep disturbance, agitation, exacerbation of anxiety, sexual dysfunction, weight gain and somnolence. Labopharm has developed a novel once-daily formulation of 150 mg and 300 mg of trazodone hydrochloride, a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder (MDD) to address patient needs in the current depression landscape, providing an effective and convenient treatment option. In a Phase III placebo controlled study of patients with MDD, Labopharm’s novel trazodone formulation demonstrated antidepressant efficacy, including rapid onset of therapeutic response, improved overall quality of sleep, a well tolerated adverse event profile, a very low rate of sexual dysfunction and no weight gain compared to placebo.
MDD is one of the most prevalent central nervous system disorders, affecting more than 120 million people worldwide. In 2007, the global market for antidepressants and related psychiatric drugs was US$19 billion, of which US$12 billion was accounted for by the U.S.
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Genaera Corporation has announced that dosing of subjects has begun in study MSI-1436C-102 (Study 102), the multiple ascending dose Phase 1b study of trodusquemine (MSI-1436) in overweight and obese type 2 diabetics. MSI-1436 is a novel therapeutic for the treatment of type 2 diabetes and obesity which works centrally and peripherally to regulate insulin and
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The use of antidepressant medications by patients with fibromyalgia syndrome is associated with a reduction in pain, sleep disturbances and depressed mood and improvement of health-related quality of life, according to an analysis of previous studies, which is published in the January 14 issue of JAMA. Fibromyalgia syndrome (FMS), which consists of chronic widespread pain
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Metabolex, Inc. has announced positive results from a Phase 2 clinical trial of MBX-8025. A summary of the results was presented at the World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy) on November 1, 2008. MBX-8025 is an oral drug candidate that is being evaluated for the treatment of dyslipidemia. The
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