The US Food and Drug Administration (FDA) has approved BioDelivery Sciences International Inc's Supplemental New Drug Application (sNDA) for a manufacturing specification change for Bunavail (buprenorphine and naloxone) buccal film (CIII).

Bunavail is a prescription medicine indicated for the maintenance treatment of opioid dependence.

The approval allows for the immediate release of Bunavail inventory to wholesalers. BDSI will be shipping product to wholesalers this morning which should make product available in pharmacies as early as Friday.

The newly released product supplies are expected to satisfy current and anticipated demand, which has increased following the October 1 initiation of a contract providing exclusive, preferred formulary status for Bunavail for Medicaid patients in the state of Tennessee.

"All of us at BDSI want to thank the Division of Anesthesia, Analgesia and Addiction Products at FDA for working with us in an expeditious and collaborative fashion to help allow patients benefiting from Bunavail treatment to maintain uninterrupted availability," said Dr. Mark A. Sirgo, president and chief executive officer.

"We also want to thank all of the patients, physicians and other health providers, including pharmacists, for their patience and support during this period of inconvenience."

Common side effects of Bunavail include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in sleep (insomnia), fatigue and sleepiness.