RALEIGH, N.C., Sept. 28, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the preliminary findings of the Company'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.
"We witnessed a high placebo response in the opioid naive segment of our patient population, particularly at our starting dose, which accounted for the overall lack of efficacy that was observed in this trial," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "This group of patients, who are not accustomed to taking opioids and prone to higher placebo effects, accounted for nearly two-thirds of the total study population. When we eliminate the BEMA Buprenorphine starting dose from the analysis, where the greatest placebo response occurred, particularly in the opioid naive group, we achieved a pain score difference between BEMA Buprenorphine and placebo that approached statis
|SOURCE BioDelivery Sciences International, Inc.|
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