RALEIGH, N.C., March 14, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Annual Report on Form 10-K for the year ended December 31, 2013 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's 2013 financials and achievements as well as an update on business operations and upcoming milestones for 2014.
In 2013, BDSI made important progress in significantly advancing and building its product portfolio in pain and addiction treatment and made meaningful strides in its continuing evolution from a development stage entity to a commercial enterprise. This included significant progress in the development of BDSI's two buprenorphine-containing products, BUNAVAIL for the maintenance treatment of opioid dependence and BEMA Buprenorphine, in partnership with Endo Pharmaceuticals, for the treatment of moderate to severe chronic pain.
A New Drug Application (NDA) for BUNAVAIL was submitted to the U.S. Food and Drug Administration (FDA) in mid-2013 and has a Prescription Drug User Fee Act (PDUFA) date of June 7, 2014. In January 2014, BDSI and Endo announced positive top-line results from the Phase 3 clinical trial of BEMA Buprenorphine in opioid naive patients. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA Buprenorphine resulted in significantly (p<0.005) improved pain relief compared to placebo. Additional secondary endpoints supported the efficacy of BEMA Buprenorphine while the most commonly reported adverse events in patients treated with BEMA Buprenorphine compared to placebo in the double blind phase of the study were nausea (10% vs. 8%), vomiting (4% vs. 2%) and constipation (4% vs. 2%). A second Phase 3 pivotal study for BEMA Buprenorphine, which is ongoing and being conducted in opioid experienced patients, is expected to report top-line results in mid-2014.
In addition to the progress on its two buprenorphine containing products, BDSI expanded its product portfolio in 2013 by in-licensing Clonidine Topical Gel, a proposed treatment for painful diabetic neuropathy. Following a positive end of Phase 2 meeting with FDA in November, BDSI will begin this quarter enrolling patients in the first of two Phase 3 studies.