ONSOLIS (BEMA Fentanyl) Data to be Presented at the American Society of Anesthesiologists (ASA) Annual Meeting
RALEIGH, N.C.--(BUSINESS WIRE)--Oct 20, 2008 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that data from clinical studies assessing the pharmacokinetics, efficacy, and safety of ONSOLIS(TM) (formerly referred to as BEMA(TM) Fentanyl) will be presented at the 2008 Annual Meeting of the American Society of Anesthesiologists (ASA) to be held from October 18 through October 22, 2008, in Orlando, Florida. The scientific poster presentations will include previously presented data from two Phase III clinical studies assessing the efficacy and safety of ONSOLIS(TM), a potential treatment for breakthrough pain (BTP) in opioid tolerant patients with cancer, as well as data summarizing the favorable pharmacokinetic profile. These data include:
"BEMA(TM) Fentanyl Shows a Favorable Pharmacokinetic Profile and Dose Linearity in Healthy Volunteers," Dr. Niraj Vasisht, Senior Vice President of Product Development and Chief Technical Officer, BioDelivery Sciences. Poster displayed Monday, October 20, from 9:00 to 11:00 a.m.
"BEMA(TM) Fentanyl Offers High Absolute Bioavailability and Favorable Efficacy and Tolerability Profiles," Dr. James North, Carolina's Pain Institute. Poster displayed Tuesday, October 21, 2:00 - 4:00 p.m.
In August, BDSI received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its lead product ONSOLIS(TM). The FDA requested modifications to the submitted risk management program and informed BioDelivery Sciences that all other aspects of the NDA review were complete. BDSI anticipates an FDA approval for ONSOLIS(TM) during the first half of 2009. In North America and Europe, the commercial rights to ONSOLIS(TM) are licensed to Meda AB.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI's pain franchise currently consists of two products in development utilizing the Company's patented BEMA(TM) oral adhesive film technology: ONSOLIS(TM), a potential treatment for "breakthrough" pain in opioid tolerant patients with cancer, and BEMA(TM) Buprenorphine, a second analgesic with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA(TM) technology and its patented Bioral(R) cochleate technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company headquarters is located in Raleigh, North Carolina, and its principal laboratory is located in Newark, New Jersey. For more information please visit www.biodeliverysciences.com.
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Posted: October 2008