Regulatory Updates, In Brief
Executive Summary
Labopharm's once-daily trazodone gets regulatory nod: FDA cleared Oleptro, Labopharm's once-daily formulation of the antidepressant trazodone, for treatment of major depressive disorder in adults Feb. 3. Commercialization plans for the extended release tablets appear to rest on when the specialty pharma confirms a marketing partner for the therapy. Labopharm said it is actively exploring alternatives that range from out-licensing to a distribution agreement under which it would retain some degree of co-promotion rights, to a full co-promotion arrangement under which the company would share sales functions with a partner. Labopharm has completed market research with physicians and third-party payers, developed a positioning and marketing campaign and finalized manufacturing and packaging arrangements, so it would appear it is readying Oleptro to be a turn-key opportunity. Oleptro should be available later this year, with a launch to be determined by the final commercialization plan
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