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Apr 25, 2007

BDSI’s Value Gets a Boost with Confirmation of Delivery Technology in Phase III Cancer Study

  • BioDelivery Sciences International reported positive outcomes with BEMA™ Fentanyl in cancer patients with breakthrough pain in its pivotal Phase III trial. Its value went up almost 60%, and today’s openning price was $7.37.

    BEMA Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal membranes. Upon administration, BEMA Fentanyl is designed to deliver a rapid, reliable dose of drug across mucous membranes.

    The study achieved the primary efficacy endpoint of the trial, Summary of Pain Intensity Difference (SPID). The results demonstrated that patients treated with BEMA 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. The double-blind, placebo-controlled portion of the study included 80 participants.

    "We are obviously very pleased with these efficacy results,” says Andrew Finn, BDSI's evp of product development. “Only five patients 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 1,200-mcg dose.”



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