BDSI Announces Its Intention To Proceed With Phase III Trials In 2006 On Its Second BEMA(TM) Product Following FDA Meeting

MORRISVILLE, N.C.--(BUSINESS WIRE)--Nov. 28, 2005--BioDelivery Sciences International, Inc. (NASDAQ:BDSI, BDSIW) announced today that it met on November 15, 2005 with the U.S. Food and Drug Administration to discuss the regulatory pathway and development plan for BEMA(TM) Long Acting Analgesic (BEMA(TM) LA), the second analgesic to be formulated with BDSI’s BEMA(TM) delivery system. At the meeting, the FDA gave its preliminary indication that BDSI will be able to utilize the FDA’s 505(b) (2) regulations for submission of a New Drug Application for BEMA(TM) LA. As a result, BDSI announced that it intends to enter clinical development with BEMA(TM) LA in the first quarter of 2006 and expects to begin Phase III trials in the second half of 2006.

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