BioDelivery Sciences Announces Positive Meeting
with FDA on a Streamlined ONSOLIS REMS with
Recently Submitted REMS Amendment Seeks to Better Facilitate Physician Prescribing for Appropriate
Patients and Improve Patient Access
September 02, 2010 01:33 PM Eastern Daylight Time
RALEIGH, N.C.--(EON: Enhanced Online News)--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).
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.
About BioDelivery Sciences International
BioDelivery Sciences (NASDAQ: BDSI) is a specialty pharmaceutical company that is leverag