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BioDelivery Sciences International, Inc. Message Board

  • biotuesday biotuesday Apr 9, 2013 7:19 AM Flag

    BioTuesdays - BioDelivery on track for mid-year NDA filing

    April 9, 2013 by leonardzehr · Leave a Comment

    BioDelivery Sciences (NASDAQ:BDSI) is on track to file a new drug application with the FDA this summer for its Bunavail treatment for opioid dependence, one of two Phase 3 candidates in its product pipeline.

    “If all goes according to plan, in mid-2014, we should have an FDA decision on the approvability of Bunavail and be preparing a submission for an NDA on our chronic pain product, BEMA buprenorphine,” president and CEO Mark Sirgo, says in an interview with BioTuesdays. “NDA filings and positive clinical readouts are important value-driving events ahead of us.”

    At the end of March, BioDelivery acquired a patented topical clonidine gel for the treatment of painful diabetic neuropathy from Arcion Therapeutics. Evidence has shown that clonidine stimulates an inhibitory receptor in the skin associated with pain fibers which, when activated, is believed to attenuate the pain associated with this condition.

    “Though we remain focused on preparing our Bunavail NDA for filing in the coming months and completing our BEMA buprenorphine chronic pain Phase 3 trials, this product acquisition allows us to build our pipeline, while applying our expertise in pain product development, utilizing the FDA’s 505(b)(2) regulatory process, and diversifying outside of opioid therapy and our BEMA technology,” Dr. Sirgo says.

    See site for rest of this week's feature on BDSI.....

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