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3/15 cls

BioDelivery Sciences International Inc. (NASDAQ:BDSI)

Piper Jaffray

Charles Duncan


Overweight from neutral)



Duncan also raised his target to $8 from $5. He said preliminary bioequivalence data for Bunavail buprenorphine/naloxone is supportive of a likely approval and suggests superiority to Suboxone buprenorphine/naloxone. Last September, BioDelivery Sciences reported top-line data from the pivotal trial that showed Bunavail was comparable to Suboxone (see BioCentury, Sept. 24, 2012). In January, the company announced preliminary data from the open-label Phase II BNX-201 trial that showed Bunavail was well tolerated after switching from Suboxone (see BioCentury, Jan. 28). Bunavail, a buprenorphine and naloxone polymer film formulated with the BioErodible MucoAdhesive (BEMA) transmucosal delivery system, is being developed under section 505(b)(2) of the Food, Drug and Cosmetic Act. BioDelivery plans to submit an NDA to FDA in mid-year for opioid dependence. Reckitt Benckiser Group plc (LSE:RB) markets Suboxone.