BioDelivery Sciences Internatio, BDSI - FDA Approval to Market ONSOLIS According to Announcement

BioDelivery Sciences Internatio, BDSI

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BioDelivery Sciences International, Inc.  and Meda AB today announced approval from the U.S. Food and Drug Administration to market ONSOLIS, formerly referred to as BEMA Fentanyl, 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.

ONSOLIS is the first product to utilize the company’s proprietary BioErodible MucoAdhesive drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa.

The approval of ONSOLIS is a landmark and transformational event for BDSI and represents the culmination of an extraordinary and focused effort by a determined group of BDSI and Meda employees,” said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences.

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