FDA Approves Bunavail for Opioid Addiction

Caroline Cassels

Disclosures

June 10, 2014

The US Food and Drug Administration (FDA) has approved a new drug for the maintenance treatment of opioid dependence.

BioDelivery Sciences International Inc announced in a release that it has received FDA approval of Bunavail (buprenorphine and naloxone) buccal film (CIII) and expects to launch the drug late in the third quarter of 2014.

According to the manufacturer, the drug has a unique adhesive "inside the cheek" delivery system that improves absorption and plasma concentrations of buprenorphine and therefore can be delivered at a lower dose, which may help reduce the potential for misuse and diversion and lessen the incidence of side effects.

The company asserts that unlike sublingual products that need to be kept in place under the tongue until they dissolve, the inside-the-cheek film allows patients to talk, swallow, and go about normal daily activities while the medication is being consistently absorbed.

"Bunavail is a novel treatment approach for the more than 2 million people in the US afflicted with opioid dependence," Gregory Sullivan, MD, principal investigator of the phase 3 Bunavail safety study and an addiction specialist and medical director of Parkway Medical Center in Birmingham, Alabama, said in a release.

"Bunavail utilizes advanced drug delivery technology to fulfill an important need for treatment options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with sublingual administration and possibly help improve treatment compliance," Dr. Sullivan added.

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