BDSI (BDSI) Announces Positive Key Secondary Efficacy Endpoint Results for BEMA Fentanyl
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BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced additional statistically significant results with BEMA Fentanyl in cancer patients with breakthrough pain in its Phase III efficacy clinical trial for the product.
Results were based on the company's continuing analysis of the secondary efficacy endpoints from the study. A key secondary endpoint was the SPID 15 (Summary of Pain Intensity Difference at 15 minutes), a measure of the speed of onset of the medication. The study data indicate that the SPID 15 was significantly higher on BEMA Fentanyl than with placebo.
On April 25, 2007, BDSI announced statistically significant results of its primary efficacy endpoint for the BEMA(TM) Fentanyl Phase III trial, SPID 30 (Summary of Pain Intensity Difference at 30 minutes). BEMA(TM) Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. Upon administration, BEMA(TM) Fentanyl is designed to deliver a rapid, reliable dose of drug across the mucous membranes.
In addition to the SPID 15 endpoint, the company also reported that the overall global analysis of the treatment, which represents each patient's overall satisfaction with the product, was also found to be statistically superior to the placebo.
Dr. Andrew Finn, BDSI's Executive Vice President of Product Development, stated: "We are very pleased with the outcome of the results from our current secondary endpoint analyses from our Phase III efficacy study which, as previously announced, we plan to present along with other efficacy and safety data at an upcoming scientific forum to be determined. We are particularly pleased to see that the onset of analgesia with BEMA(TM) Fentanyl is rapid, since a quick onset of action is one of the anticipated features of delivering fentanyl through the mucosal membrane and a major need for our target patients."
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