BioDelivery Sciences International, a developer of drug delivery technologies, and Endo Health Solutions have started enrolling patients for its Phase 3 clinical program of BEMA Buprenorphine, designed as a treatment for moderate to severe chronic pain.
The Phase 3 program comprises two efficacy studies, one in opioid naive and one in opioid experienced subjects, along with an open-label safety study.
Both efficacy studies, which are double-blind, randomized, placebo-controlled, are designed to evaluate the potential of BEMA Buprenorphin in treating patients with chronic lower back pain.
At completion of study enrollment and database lock for each trial and and subsequently, for the acceptance of filing of the NDA by the FDA, BDSI will receive a total of $30m from Endo.
BioDelivery Sciences International president and chief executive officer Mark Sirgo said the company is pleased to be back in the clinic with the two important pivotal studies and to have enrolled its first patient.
"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," Sirgo added.
"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."
