Labopharm Inc. (DDSS,DDS.TO), a Laval, Canada-based specialty pharmaceutical company, Monday said its New Drug Application or NDA for the novel once-daily formulation of trazodone for the treatment of major depressive disorder or MDD has been accepted for review and filed by the U.S. Food and Drug Administration. The action date under the Prescription Drug User Fee Act is July 18, 2009.
Trazodone is a serotonin antagonist reuptake inhibitor. Labopharm developed a novel once-daily formulation of 150 mg and 300 mg of trazodone hydrochloride for treating MDD.
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. 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 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 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 globally. In 2007, the global market for antidepressants and related psychiatric drugs was $19 billion, of which $12 billion was accounted for by the U.S.
DDSS closed Friday's regular trade at $0.46, down from the previous close of $0.49, on 14,900 shares.
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