FDA Approves BioDelivery Sciences' Bunavail For Opioid Dependence

BioDelivery Sciences International (BDSI) announced in a press release that the Food and Drug Administration (FDA) has approved Bunavail (buprenorphine and naloxone). The buccal film (inside of the cheek) is indicated for patients with opioid dependence in conjunction with counseling and psychosocial support. BDSI stated that Bunavail will compete in a growing $1.7 billion U.S. market in opioid dependence. The company plans to launch its new product late in the third quarter of 2014.

Gregory Sullivan, M.D., lead investigator in Bunavail trials and an addiction specialist at the Parkway Medical Center in Birmingham, Alabama, said, "Bunavail is a novel treatment approach for the more than two million people in the U.S. afflicted with opioid dependence.”

Bunavail

Bunavail (buprenorphine and naloxone) is a buccal film, delivering its medicine inside the cheek for longer lasting treatment without the inconvenience of under the tongue dissolution. Sublingual products under the tongue must stay in place while dissolving, interfering with the patient’s need to speak and swallow. The advanced drug delivery technology improves drug absorption and the patient’s convenience, making treatment compliance more likely. However, since opioid dependence is a complicated biochemical and psychosocial condition, the drug is to be prescribed along with a comprehensive plan for counseling and psychosocial support.

The drug uses BDSI’s proprietary technology, BioErodible MucoAdhesive (BEMA). Compared to Suboxone, the market leader in the opioid dependence category, Bunavail has twice the bioavailability. Due to the BEMA drug delivery system and bioavailability, patients can achieve the same amount of plasma concentrations of buprenorphine as half the dose of Suboxone. Lessening the dose may help reduce side effects and misuse of the drug.

The FDA based its approval in part on a Phase III trial of 249 patients taking Bunavail or Suboxone. Bunavail showed safety and efficacy for opioid dependence maintenance treatment. The study had a high retention rate of patients and few patients that tested positive for opioids. Most participants tolerated the buccal film, saying it was pleasant tasting and easy to use. About half of the patients in the Suboxone arm experienced constipation. Two thirds of those patients, when switched to Bunavail, had their constipation resolve.

Bunavail Marketing

BDSI intends to market Bunavail in the third quarter of 2014. Quintiles is contracted to provide marketing support in the U.S. with part of its duties deploying a dedicated sales staff. Ashfield Market Access will provide managed markets and trade support to maximize patient access. BDSI is seeking commercial partnerships for Bunavail marketing outside of the U.S.