BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, and US-based diversified healthcare company, Endo Health Solutions Inc. have initiated phase 3 clinical programme for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. The phase 3 programme will consist of two efficacy studies, one in opioid naïve and one in opioid experienced subjects. Both studies are anticipated to be completed by late 2013 or early 2014.
Both studies are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. The studies have been designed through a cooperative effort between BDSI and Endo, along with input from the US Food and Drug Administration (FDA). These two studies, along with an open-label safety study, comprise the phase 3 programme and the basis for a New Drug Application (NDA).
Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the NDA by the FDA. These payments will total $30 million.
“We are very pleased to be back in the clinic with these two important pivotal studies and to have enrolled our first patient,” said Dr. Mark A. Sirgo, president and chief executive officer of BDSI. “This has been a tremendous cooperative effort between the teams at BDSI and Endo since January that we believe gives us the best chance of obtaining a positive clinical outcome. We continue to believe that BEMA Buprenorphine has the potential to address some of the important unmet needs in the treatment of chronic pain and look forward to expeditiously progressing the program forward.”
“With a long-standing history and success in developing innovative solutions for pain management, BEMA Buprenorphine represents a significant asset and a high priority programme to Endo as we continue our commitment to serving as an integrated health solutions provider,” said Dr. Ivan Gergel, M.D., executive vice president, R&D and chief scientific officer, Endo. “We are pleased to have the Phase 3 program now underway.”