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news.BioDelivery Sciences International (BDSI) has recruited and dosed first patient in its Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.
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BEMA Buprenorphine utilises BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa to deliver the opioid analgesic buprenorphine.
BDSI Product Development executive vice president Andrew Finn said that enrollment of the first patient into the BEMA Buprenorphine Phase 3 program marks their continued progress in making this novel treatment available for patients with moderate to severe chronic pain.
"Positive findings from this study would then allow for an NDA filing in the first half of 2012," Finn said.
BDSI president, CEO Mark Sirgo said that BEMA Buprenorphine could play an important future role in the treatment of chronic pain and may offer distinct advantages over other marketed opioid analgesics including oxycodone, hydrocodone, and morphine.