BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced the approval by the U.S. Food and Drug Administration (FDA) of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS® (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. The new formulation was submitted to address previously announced appearance-related changes.

Early this year, BDSI announced that it entered into an assignment and revenue sharing agreement with its partner for ONSOLIS, Meda Pharmaceuticals, to return the marketing authorization back to BDSI and the right to seek marketing authorizations for ONSOLIS in the United States, Canada and Mexico. Meda retains the rights to ONSOLIS outside the U.S., where it is marketed in the E.U. as BREAKYL. ONSOLIS is separately licensed by BDSI in Taiwan and South Korea.

"We are pleased to have obtained FDA approval of our sNDA and to now be in a position to move toward returning ONSOLIS to the U.S. marketplace," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "ONSOLIS remains an important differentiated fentanyl containing product for this indication given that it is the only product for buccal administration, providing patients with an alternative dosing option."

Dr. Sirgo continued, "Although we have options for ONSOLIS, including commercializing it on our own, our current plan is to determine the value we can secure in a partnership with a company that has access to the target physician audience. We have been engaged with a number of potential partners, and with this approval, we can now proceed forward with those discussions in earnest. We will provide more definitive timing in the near future about the reintroduction but this would not be prior to 2016."

ONSOLIS will be part of the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program, which is an FDA-required program designed to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines. The purpose of the TIRF REMS Access program is to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines.