(Raleigh, N.C.) BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced the approval of a New Drug Submission (NDS) by Health Canada, the regulatory authority in Canada, for ONSOLIS (fentanyl buccal soluble film) in the management of breakthrough pain in opioid-tolerant adult patients with cancer. ONSOLIS is the first product approved in Canada for this indication.

ONSOLIS will be marketed in Canada by Meda Valeant Pharma Canada Inc., a joint venture between BDSI’s commercial partner, Meda AB, and Valeant Canada Limited. ONSOLIS will be launched in the third quarter of this year.

“The regulatory approval of ONSOLIS in Canada represents the culmination of a great collaborative effort between BDSI, Meda, and Valeant,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. “ONSOLIS provides an important new option to manage the potentially debilitating effects of breakthrough pain in opioid-tolerant individuals with cancer. As the first oral transmucosal fentanyl product in Canada, our commercial partners have the opportunity to establish and build an important new market for ONSOLIS.”

Under the terms of its agreement with Meda, BioDelivery Sciences will receive a double-digit royalty on net sales.

In addition to approvals in the U.S. and Canada, ONSOLIS is currently under regulatory review in the European Union.

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 BDSI’s patented BEMA buccal soluble film technology. ONSOLIS (fentanyl buccal soluble film) was approved by FDA in July 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. BDSI’s second pain product in development, BEMA Buprenorphine, is in Phase 2 clinical development for the treatment of chronic pain, and entering Phase 1 as a higher dose formulation 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 is also working with its patented Bioral cochleate technology to facilitate oral dosing of drugs that would otherwise require intravenous administration. The first product candidate under development using this technology is Bioral Amphotericin B. BDSI’s headquarters is located in Raleigh, North Carolina.