BioDelivery Sciences International (BDSI) and Endo Health Solutions (ENDP) have announced the commencement of the Phase 3 clinical programme for BEMA Buprenorphine for moderate to severe chronic pain.
The programme consists of two efficacy studies, one in opioid naive and one in opioid experienced subjects, and is expected to be completed by late 2013 or early 2014.
BDSI president and chief executive officer Dr. Mark Sirgo said that the first patient has been enrolled in the two pivotal studies.
"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,"Dr.Sirgo added.
The double-blind, randomised, placebo-controlled, enriched-enrolment studies in patients with chronic lower back pain were designed through a cooperative effort between BDSI and Endo, along with input from the FDA.
As per the licensing contract for BEMA Buprenorphine, Endo will make milestone payments at the completion of study enrolment and database lock for each trial, and subsequently, for the NDA acceptance by the FDA. The payments will total $30m.
Endo R&D executive vice president and chief scientific officer Dr. Ivan Gergel said, "With a long-standing history and success in developing innovative solutions for pain management, BEMA Buprenorphine represents a significant asset and a high priority program to Endo as we continue our commitment to serving as an integrated health solutions provider."