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news.Labopharm, a specialty pharmaceutical company, has announced that its new drug application for the company's novel once-daily formulation of trazodone, a serotonin antagonist reuptake inhibitor, for the treatment of major depressive disorder, has been accepted for review and filed by the FDA. The action date under the Prescription Drug User Fee Act is July 18, 2009.
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Labopharm’s new drug application (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, 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.
In a Phase III placebo controlled study of patients with major depressive disorder, 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.