BioCentury
ARTICLE | Clinical News

BEMA Buprenorphine meets in second Phase III pain trial

July 7, 2014 11:41 PM UTC

Endo International plc (NASDAQ:ENDP; TSX:ENL) and partner BioDelivery Sciences International Inc. (NASDAQ:BDSI) said BEMA Buprenorphine met the primary endpoint of improving mean daily average pain intensity scores from baseline to week 12 vs. placebo in the Phase III BUP-307 trial to treat moderate to severe chronic pain. The double-blind, U.S. trial enrolled 511 opioid-experienced patients with chronic lower back pain. In January, the partners said BEMA Buprenorphine met the same primary endpoint vs. placebo in a separate Phase III trial that enrolled opioid-naïve patients. Endo said it plans to submit an NDA "as soon as possible," and that the application will cover management of pain severe enough to require daily around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate in both opioid-naïve and opioid-experienced patients.

Endo has exclusive, worldwide rights from BioDelivery to develop and commercialize BEMA Buprenorphine -- which is buprenorphine formulated with BioDelivery's BioErodible MucoAdhesive (BEMA) transmucosal delivery system -- for chronic pain. The partners are developing the product under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...