|By PR Newswire||
|April 7, 2014 09:40 AM EDT||
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) 45th 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.
BDSI's pain franchise consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it will be marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).
BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Pharmaceuticals. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.
An NDA for BUNAVAIL, a BEMA formulation of buprenorphine used in combination with naloxone, is currently under review for the maintenance treatment of opioid dependence and has a PDUFA date of June 7, 2014.
BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYL™ is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners.
© BioDelivery Sciences International, Inc. All rights reserved.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto (including, without limitation, at the presentations described herein) contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the FDA's review of BUNAVAIL) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
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