MORRISVILLE, N.C.--(BUSINESS WIRE)--Apr 25, 2007 - BioDelivery
Sciences International, Inc. (Nasdaq: BDSI) announced today
statistically significant results with BEMA(TM) 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 BEMA(TM)
Fentanyl showed a statistically significant improvement on the
primary efficacy endpoint at 30 minutes (SPID 30) compared to
placebo (p less than 0.004), meaning a greater reduction in pain.
Eighty (80) patients participated in the double-blind,
placebo-controlled portion of the study.
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 Fentanyl is designed to deliver a rapid, reliable dose of drug
across mucous membranes.
Dr. Andrew Finn, BDSI's 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(TM) 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."
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