Phase 3 Study of BEMA Buprenorphine for Chronic Pain

BioDelivery Sciences International, Inc. announced preliminary findings from its Phase 3 study of BioErodible MucoAdhesive (BEMA) buprenorphine for the treatment of moderate to severe chronic pain in a mixed opioid-naive and opioid-experienced population. The randomized, placebo-controlled study's primary endpoint--overall pain intensity difference between BEMA buprenorphine and placebo--was not achieved. However, the manufacturer believes that the totality of the study results favors BEMA buprenorphine, including a near statistically significant difference between BEMA buprenorphine and placebo in the opioid experienced group of patients in the trial (P=0.067). In addition, when eliminating the group of patients that did not titrate beyond the starting dose, a statistically significant difference between BEMA buprenorphine and placebo (P=0.025) was identified.  With the knowledge gained from this study, the BDSI plans to initiate a second efficacy study in the near future.

Buprenorphine is a partial agonist of the mu-opioid receptor. It is a potent analgesic with a relatively long duration of action.  Buprenorphine is a Schedule III controlled substance. 

For more information call (919) 582-9050 or visit www.bdsi.com.