RALEIGH, N.C., Nov. 12, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, 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 2013 and 2014.
As reported on October 9, 2013, the New Drug Application (NDA) for BDSI's BUNAVAIL (buprenorphine and naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), and the agency has assigned a Prescription Drug User Fee Act (PDUFA) date of June 7, 2014. BDSI believes BUNAVAIL may offer meaningful advantages over existing opioid dependence treatments and could provide an alternative to the over 2 million people estimated in the U.S. to be opioid dependent. This would create the potential for BUNAVAIL to compete in the estimated $1.5 billion opioid dependence market.
BDSI and Endo Health Solutions, Inc. also provided a recent update on the BEMA Buprenorphine Phase 3 clinical development program for the treatment of chronic pain. Interim analyses were conducted as part of the Phase 3 protocol to allow for adjustments to the sample size in order to maintain appropriate study power to detect statistically significant differences between BEMA Buprenorphine and placebo. The analyses determined that no sample size adjustment was necessary for the opioid naive study. However, additional patients will be added to the ongoing opioid experienced trial. Results from the opioid naive trial are expected in early 2014 and data from the opioid experienced trial will be available in mid-2014.