BEMA Buprenorphine Phase 2 Study Results Selected for Presentation at Pain Week 2010
RALEIGH, N.C.--(BUSINESS WIRE)--Aug 30, 2010 - BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced today that its abstract showing the results of a Phase 2 clinical study of BEMA Buprenorphine in the treatment of pain has been selected for oral presentation at Pain Week 2010, a national conference educating frontline clinicians who are faced with treating patients with pain. The presentation will take place on Friday, September 10, as part of the 7:00 - 9:00 AM podium presentation session.
BDSI previously announced positive top-line results from the study which showed that BEMA Buprenorphine demonstrated a statistically significant improvement compared to placebo in the primary efficacy endpoint, SPID-8 (sum of pain intensity differences at 8 hours; baseline observation carried forward analysis).
In addition, data will be presented which looked at a subset of patients with severe pain, where the analgesic efficacy of BEMA Buprenorphine was more profound.
About BioDelivery Sciences International
BioDelivery Sciences (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 oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the Company's patented BEMA buccal soluble film technology. ONSOLIS (fentanyl buccal soluble film) was approved by FDA on July 16, 2009 for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. The commercial rights to ONSOLIS are licensed to Meda AB, who launched ONSOLIS in the U.S. last October, and Kunwha Pharmaceutical Co. Ltd. BDSI's second pain product, BEMA Buprenorphine, completed Phase 2 clinical development for the treatment of pain; a higher dose formulation is being developed for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA “Triptan”). BDSI's headquarters is located in Raleigh, North Carolina. For more information please visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc.
Cautionary Note on Forward-Looking Statements
This press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the “Company”) related thereto or at the presentation 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,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” 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 results of clinical trials of BEMA Buprenorphine) may differ significantly from those set forth or implied 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 publically update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Contact: BioDelivery Sciences International, Inc.
Vice President, Marketing & Corporate Development
Posted: August 2010