RALEIGH, N.C., Jan. 30, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today announced that data from clinical studies of BUNAVAIL have been accepted for presentation at the American Society of Addiction Medicine (ASAM) 45 th Annual Medical-Scientific Conference, April 10-13, 2014 in Orlando, Florida.
Four abstracts will be presented highlighting data from the clinical development program, which incudes the pivotal bioequivalence study of BUNAVAIL compared to Suboxone tablets and a safety study conducted in 249 subjects undergoing maintenance treatment for opioid dependence with Suboxone film or tablets who were converted to BUNAVAIL for 12 weeks.
"We are honored to have multiple abstracts accepted to such a prestigious addiction medicine forum and to publicly present this data for the first time," said Andrew L Finn, Pharm D, Executive Vice President of Product Development at BDSI. "The data will highlight the unique pharmacokinetic characteristics and the clinical profile of BUNAVAIL as well as the high acceptance of BUNAVAIL by patients who converted from Suboxone therapy."The New Drug Application for BUNAVAIL is currently under review by the U.S. Food and Drug Administration with a PDUFA date of June 7, 2014. BUNAVAIL utilizes BDSI's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent. BUNAVAIL was designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms. Presentation Titles and Session Details Oral presentation by Kent Hoffman, DO Buprenorphine/Naloxone Buccal Film is Well Tolerated in Opioid - Dependent Patients Converted from Suboxone Sunday, April 13, 2014, 8:00 am – 10:00 am Poster presentation by Gregory B. Sullivan, MD Buprenorphine/Naloxone Buccal Film: A Novel Approach in the Treatment of Opioid Dependence Friday, April 11, 2014, 12:30 pm – 2:30 pm Poster presentation by Niraj Vasisht, PhD, Senior Vice President, Product Development and Chief Technical Officer of BDSI Buprenorphine/Naloxone Buccal Film: Relative Buprenorphine Bioavailability Approximately Twice that of Suboxone Friday, April 11, 2014, 12:30 pm – 2:30 pm Poster presentation by Lynn Webster, MD Low-Dose Naloxone Provides an Abuse Deterrent Effect to Buprenorphine Doses Friday, April 11, 2014, 12:30 pm – 2:30 pm About BioDelivery Sciences International