The initial findings of BioDelivery Sciences International Incorporated (BDSI) in regard to their random, placebo-induced, Phase 3 clinical study of BEMA Buprenorphine, used for the treatment of moderate to severe chronic pain in mixed opioid na?ve and opioid treated population were revealed recently. The main thrust of the study which is to compare the overall pain intensity difference between BEMA Buprenorphine and placebo was not realized, but BDSI said that generally, the study results were inclined to support BEMA Buprenorphine to include the statistic-significant difference between BEMA Buprenorphine and placebo in the patients treated with opioid experience in the tests conducted (relatively equal to p=0.067).
There was also a statistically significant difference between BEMA Buprenorphine and placebo when there was segregation of patients not undergoing titrate from the starting dose (p=0.025). The company, armed with the findings from this study, is pondering on conducting another efficacy study that is estimated to take 9 months to complete.
According to Dr. Andrew Finn, Executive Vice President of Product Development, there has been a high placebo response in the opioid na?ve sector of the patient group, specifically with the starting dose, which was responsible for the lack of efficacy that was revealed in this study.
BioDelivery stock is still struggling badly, falling to as low as $1.24 during the last week. This is the all-time low for the company that has been around since summer 2002, the all-time high being $6.94, recorded in June 2009. Nevertheless, BDSI might be a stock to watch due to the current low price.
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