BioDelivery Sciences Announces FDA Approval Of New Formulation Of ONSOLIS CII

(RTTNews) - BioDelivery Sciences International, Inc. (BDSI) announced the approval by the U.S. FDA of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS 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.

"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. 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. We will provide more definitive timing in the near future about the reintroduction but this would not be prior to 2016," said Mark Sirgo, President and CEO.