FDA accepts Labopharm’s NDA for formulation of trazodone
Using a novel technique developed by Mitchell Sogin of the Marine Biological Laboratory (MBL) to identify different types of bacteria, scientists have completed the most precise survey to date of how microbial communities in the human gut respond to antibiotic treatment. Sogin, director of the MBL’s Josephine Bay Paul Center, and Susan Huse of the
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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.
Phase III data on carisbamate, an investigational compound recently filed with the FDA for the adjunctive treatment of partial onset seizures (POS) in patients 16 years of age and older, was presented during the poster sessions of the 32nd Annual Meeting of the American Epilepsy Society. Results from two identical placebo-controlled clinical trials investigating
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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 first melatonergic antidepressant - Valdoxan/Thymanax (agomelatine) - has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD). Upon approval by the European Commission in early 2009, Valdoxan is expected to be
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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
Full Post: Metabolex announces positive results from phase 2 trial of MBX-8025