BioDelivery Sciences International, Inc received Health Canada's approval for New Drug Submission, 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 US and Canada, Onsolis is currently under regulatory review in the European Union.

BioDelivery Sciences 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.