RALEIGH, N.C., Jan. 10, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced updates to the company's anticipated 2014 milestones for its product portfolio, including the imminent database lock for the Phase 3 clinical study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in opioid naive subjects, with topline data expected late January or early February.
The database for the BEMA Buprenorphine Phase 3 clinical study in opioid naive patients with chronic pain is expected to be locked shortly by BDSI's partner, Endo Pharmaceuticals. This event is expected to trigger a $10 million milestone payment from Endo per the licensing and development agreement signed in January 2012.
In addition, based on recruitment rates in a second Phase 3 clinical study of BEMA Buprenorphine in an opioid experienced patient group, the database for this trial is anticipated to be locked by mid-2014, with results following shortly thereafter.BDSI also continues to develop the commercialization plans for the launch of BUNAVAIL for the maintenance treatment of opioid dependence. As previously reported, the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of June 7, 2014 for BUNAVAIL, which if approved is anticipated to launch late third quarter 2014. BDSI estimates annual peak U.S. sales of BUNAVAIL of up to $250 million. "This year will potentially provide two of the most significant value driving milestones that our company has ever experienced," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We look forward to the results of our two Phase 3 studies for BEMA Buprenorphine for the treatment of chronic pain, which could potentially lead to an NDA submission late this year. We are also extremely excited about the prospects of an NDA approval for BUNAVAIL this coming June with a launch shortly thereafter. Finally, initiating enrollment in our Phase 3 program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy this quarter gives us our third exciting potential entry into the pain space." Dr. Sirgo concluded, "Overall, this coming year will be an exceptionally exciting one for BDSI, and we look forward to the forthcoming milestones, which will be instrumental in enhancing the future value of the company."