BioDelivery Sciences International, Inc. has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Bunavail (buprenorphine and naloxone) buccal film (CIII), revising the indication to include the use of Bunavail for the initiation of buprenorphine treatment for opioid dependence. BioDelivery Sciences International, Inc. is headquartered in Raleigh, NC.

Indications: Bunavail Buccal Film (CIII) is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).

Dosage/administration: Bunavail buccal film is applied as a single daily dose. The recommended daily dose for maintenance is 8.4 mg/1.4 mg.

Adverse reactions: Adverse events commonly observed with administration of Bunavail buccal films during clinical trials are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, and pain.