BioDelivery Sciences International Inc. (BDSI)

[surf1944]

5:17PM BioDelivery Sciences releases negative drug news; primary endpoint of the study was not achieved, however, BDSI believes that the totality of the study results favors BEMA Buprenorphine (BDSI) 3.06 -0.10 : BDSI announced the preliminary findings of the Co's randomized, placebo-controlled, Phase 3 clinical study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in a mixed opioid naive and opioid experienced population. The primary endpoint of the study, overall pain intensity difference between BEMA Buprenorphine and placebo, was not achieved; however, BDSI 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 Company plans to initiate a second efficacy study in the near future that will take approximately nine months to complete. (Stock is still halted)