BioDelivery Sciences International Inc. (BDSI)

[surf1944]

BioDelivery Sciences Provides Update on Status of Modified REMS Program for ONSOLIS

Press Release Source: BioDelivery Sciences International, Inc. On Thursday June 2, 2011, 4:00 pm EDT

RALEIGH, N.C., June 2, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI®) (Nasdaq:BDSI - News) provided an update on progress with the modified REMS (Risk Evaluation and Mitigation Strategy) program for ONSOLIS (fentanyl buccal soluble film), which among other changes, is expected to allow for dispensing of ONSOLIS from retail pharmacies.

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BDSI's commercial partner Meda Pharmaceuticals submitted the modified REMS to the U.S. Food and Drug Administration (FDA) in early December 2010. Amendments to REMS programs typically fall under a six month FDA review timeframe, but the FDA has no obligation to meet such timeline.

"Meda and BDSI continue a close dialogue and final document exchange with the FDA in order to gain approval of a modified REMS program that seeks to reduce some of the unintended barriers to prescribing and expand access to ONSOLIS for appropriate patients by making it available in retail pharmacies," said Dr. David Wright, Vice President, Regulatory Affairs for BDSI. "This amendment was a document intensive undertaking involving the creation of numerous documents which are under final review by various levels and disciplines within the FDA. While we anticipated this review would be completed by this time, we are working diligently with our partner Meda and the FDA on the few remaining components that we believe will allow for the final approval of the modified REMS program sometime this summer. Given this final approval is dependent largely on the FDA's constraints, we cannot be any more precise regarding the exact timing for ultimate approval."