BioDelivery Sciences announced that the Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Bunavail (buprenorphine and naloxone) buccal film. The approval is related to a manufacturing specification change for the drug.

Bunavail is a Schedule III controlled substance indicated as maintenance treatment of opioid dependence and as part of a complete treatment plan to include counseling and psychosocial support. Bunavail incorporates BioErodible MucoAdhesive (BEMA), the company’s patented, thin film drug delivery technology. This enables efficient and convenient delivery of buprenorphine without some of the administration difficulties associated with sublingual dosage forms that are currently on the market.

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Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms, if administered parenterally, in individuals physically dependent on full opioid agonists.

Bunavail is available as 2.1mg/0.3mg, 4.2mg/0.7mg, and 6.3mg/1mg strengths in 30-count boxes. The approval allows for the immediate release of Bunavail inventory to wholesalers.

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