RALEIGH, N.C., Aug. 7, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's recent achievements and an update on business operations and upcoming milestones for 2014.
In June, BDSI received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BUNAVAIL is the first and only FDA-approved buccal film formulation of buprenorphine and naloxone and will compete in the $1.7 billion and growing U.S. opioid dependence market. BDSI expects to launch BUNAVAIL late in the third quarter of 2014 with a dedicated U.S. sales force. BDSI plans to share additional details on its launch plans at its Investor and Analyst Luncheon on September 5, 2014 in New York City.
On July 7, Endo Pharmaceuticals and BDSI announced positive top-line results from its second pivotal Phase 3 efficacy study of BEMA Buprenorphine in opioid-experienced patients. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA Buprenorphine resulted in significantly improved chronic pain relief compared to placebo. Additional secondary endpoints were supportive of the efficacy of BEMA Buprenorphine compared to placebo. The locking of the database for the opioid-experienced study also triggered a $10 million milestone payable from Endo to BDSI. Endo and BDSI plan to submit an NDA to FDA by year-end or early 2015.
Earlier in the week, BDSI announced that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). The encouraging outcome reported in this interim analysis was performed on data from the first 50% of patients who completed the study. The purpose of the interim analysis was to allow for a sample size adjustment if necessary to maintain appropriate statistical power to detect a treatment effect between Clonidine Topical Gel and placebo. As a result of the interim analysis, a total of approximately 80 additional patients will be added to the ongoing trial in an effort to maintain 90% power to detect a statistically significant difference between Clonidine Topical Gel and placebo. This will extend patient enrollment until year-end with top-line results expected by the end of the first quarter of 2015. This is the first of two pivotal trials that would be required for submission of an NDA to the FDA. The FDA has granted Fast Track designation for the program, which recognizes the need for developing new therapies for this serious condition.