MORRISVILLE, N.C.April 25, 2007 -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today statistically significant results with BEMA Fentanyl in cancer patients with breakthrough pain in its pivotal Phase III efficacy clinical trial for the product. The results are based on achievement of the primary efficacy endpoint of the trial, Summary of Pain Intensity Difference (SPID), compared to placebo.
The results demonstrated that patients treated with BEMATM Fentanyl showed a statistically significant improvement on the primary efficacy endpoint at 30 minutes (SPID 30) compared to placebo (p<0.004), meaning a greater reduction in pain. Eighty (80) patients participated in the double-blind, placebo-controlled portion of the study.
BEMA 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 Fentanyl is designed to deliver a rapid, reliable dose of drug across mucous membranes.
Dr. Andrew Finn, BDSIs Executive Vice President of Product Development, stated "We are obviously very pleased with these efficacy results. Only five patients (approximately 3% of those patients entering the initial titration phase of the study) were unable to achieve adequate pain relief. We believe this high level of pain control is attributable to the efficient, reliable absorption from the buccal mucosa, the ease of application of the BEMA Fentanyl product and the ability to titrate across a wide range of doses up to and including our 1200 mcg dose. Importantly, the results also demonstrated that BEMA Fentanyl was well-tolerated by patients in the trial, with no reported drug-related changes to the oral mucosa, which is important for cancer patients who may also have oral ulcerations as a result of a weakened immune system."