General Information

Bunavail buccal film contains buprenorphine and naloxone. Buprenorphine is a partial aganist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors.

Bunavail is specifically indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Bunavail is supplied as a buccal film for application to the buccal mucosa. The recommended dosage of Bunavail buccal film is 8.4/1.4 mg per day as a single daily dose. The dosage of Bunavail buccal film should be progressively adjusted in increments/decrements of 2.1/0.3 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. The maintenance dose of Bunavail buccal film is generally in the range of 2.1/0.3 mg buprenorphine/naloxone to 12.6/2.1 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been demonstrated to provide any clinical advantage.

Clinical Results

FDA Approval

The FDA approval of Bunavail was based on pharmacokinetic, bioavailability and bioequivalence studies of Bunavail to a reference product, Suboxone. The studies demonstrated that key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug exposure (area under the curve or AUC), for buprenorphine were comparable to Suboxone, and that the same parameters for naloxone were similar or less than Suboxone.

Mechanism of Action

Bunavail buccal film is a citrus flavored oral transmucosal form of buprenorphine and naloxone. 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.