BioDelivery Sciences International (NASDAQ:BDSI) said Thursday that proposed modifications to its risk evaluation strategy could potentially lead to greater access to a drug used to treat pain in cancer patients.
Onsolis, approved by the FDA in July of 2009, is used the treat pain in patients with cancer over the age of 18 who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.
The US Food and Drug Administration and Meda discussed modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program of Onsolis that seek to reduce unintended barriers to prescribing the drug and expand its access for patients.
“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. “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.”
The company said it believes the proposed modifications, which remain under FDA review, will give healthcare providers a greater ability to prescribe ONSOLIS and improve patient access through broadened distribution.