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BDSI BEMA fentanyl NDA in Q2’07

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

BioDelivery Sciences plans to submit an NDA for its BEMA fentanyl oral adhesive disc in the second quarter of 2007, the company says Sept. 20. The Morrissville, N.C. firm is targeting use in breakthrough pain and projects $250 mil. in peak sales (1Pharmaceutical Approvals Monthly March 2006, p. 19). On Sept. 26, BDSI announced that the Research Advisory Panel of California approved the restart of two Phase III protocols of the proprietary fentanyl formulation. BDSI received a "not approvable" letter Feb. 28 for its antiemetic Emezine (prochlorperazine) for use in severe nausea and vomiting and subsequently began highlighting its BEMA formulations, which include a long-acting analgesic and zolpidem (Sanofi-Aventis' Ambien and tentatively approved generics)...

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