BioDelivery Sciences Receives FDA Approval For Opioid Addiction Drug

BioDelivery Sciences International announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Bunavail (buprenorphine and naloxone) buccal film (CIII).

Bunavail is indicated to treat opioid dependence as an adjunct to a complete treatment plan that includes counseling and psychosocial support. The drug is designed using the company’s advanced drug delivery technology, BioErodible MucoAdhesive (BEMA) which enables efficient and convenient delivery of buprenorphine.

With twice the bioavailability compared to Suboxone, Bunavail delivers plasma concentrations in half the dose. This helps reduce risk of misuse and potentially lessens the incidence of side effects as well.

“Bunavail is a novel treatment approach for the more than two million people in the U.S. afflicted with opioid dependence," said Gregory Sullivan, an addiction specialist and Medical Director of Parkway Medical Center in Birmingham, Alabama.

The product is the first mucoadhesive buccal film formulation of buprenorphine to challenge Suboxone sublingual film in the market area. Dr. Sullivan, who was also principal investigator of the Phase 3 BUNAVAIL safety study, said that BUNAVAIL showed high study retention rate and low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period of the study which involved 249 patients.

Tim Lepak, President of the National Alliance of Advocates for Buprenorphine Treatment (NAABT), said, “People with opioid addiction face significant challenges in their efforts to rebuild their lives and achieve sustained addiction remission. It is important that patients have treatment options that are effective, safe and easy to use in order to provide them with their best chance for success. I believe people addicted to prescription opioids and heroin will welcome BUNAVAIL as a novel treatment option.”

BDSI said it expects to launch Bunavail late in the third quarter of the year and has entered into partnership with Ashfield Market Access to supply managed markets and trade support for Bunavail.