BDSI announces positive meeting with FDA, Meda on REMS program for ONSOLIS

Sep 3 2010

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) today announced a positive meeting with the U.S. Food and Drug Administration (FDA), Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film).

“Much has been learned over the past year from the implementation of the first REMS for an opioid product”

At the meeting, FDA and Meda discussed REMS modifications that seek to reduce unintended barriers to prescribing and expand access to ONSOLIS for appropriate patients.

BDSI believes that the recently submitted proposed REMS modifications, which are under FDA review, should facilitate the ability of healthcare providers to prescribe ONSOLIS for appropriate patients as well as improve patient access through broadened distribution.

"Much has been learned over the past year from the implementation of the first REMS for an opioid product," said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI. "We have been working closely with our commercial partner Meda, who has provided the FDA with proposed improvements to the REMS based on first-hand experience in the marketplace. Given the current high product acceptance from healthcare providers and patients, a streamlined REMS with expanded distribution could place ONSOLIS in a position to compete more favorably in the future."

BDSI deferred a public announcement of this meeting pending its receipt and review of the official minutes from the FDA meeting, which takes approximately 30 days to receive from FDA.