BioDelivery Sciences announced that the FDA has approved Bunavail (buprenorphine and naloxone) buccal film for the maintenance treatment of opioid dependence as part of a complete treatment plan, including counseling and psychosocial support. Bunavail, a Schedule CIII drug, is the first buccal formulation for buprenorphine and naloxone.

Bunavail buccal film utilizes BioErodible MucoAdhesive (BEMA) technology that allows efficient delivery of buprenorphine in spite of the difficulties associated with sublingual dosage forms. Bunavail also has twice the bioavailability of buprenorphine vs. Suboxone (Reckitt Benckiser). The lower required dose may help decrease the misuse and diversion potential.

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The approval of Bunavail was assessed in a Phase 3 clinical trial in which 249 patients were converted from Suboxone sublingual tablet or film to Bunavail. Bunavail showed favorable safety and efficacy in the maintenance treatment of opioid dependence as demonstrated by the high study retention rate and the low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period. Also, a majority of patients found Bunavail easy to use and pleasant in taste.

Bunavail buccal film is expected to launch in the late 3rd quarter of 2014.

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