RALEIGH, N.C., April 7, 2014 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that data from clinical studies of BUNAVAIL will be presented 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 includes 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.
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 BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.