BDSI, Meda, FDA talk about streamlining REMS for Onsolis

Raleigh, NC-based BioDelivery Sciences International has disclosed a July meeting with the FDA and Swedish pharmaceutical company Meda regarding the Onsolis cancer-pain treatment. The talks centered on plans to streamline the risk evaluation and mitigation strategy (REMS) for BDSI's drug-delivery system for Onsolis that consists of a small dissolvable film applied to the lining of the cheek rather than tablets or intravenous injections.

At the meeting, FDA and Meda discussed ways to reduce unintended barriers to prescribing and expand access to Onsolis for appropriate patients.

"Much has been learned over the past year from the implementation of the first REMS for an opioid product," says Andrew Finn, executive VP of product development for BDSI, in a statement. "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.

Onsolis uses BDSI's BioErodible MucoAdhesive drug delivery technology, which is a small, bioerodible polymer film that is placed on the inner lining of the cheek. It's an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer.

- read the BDSI release
- get a report from Dow Jones Newswire
- see this from the Triangle Business Journal
- and more on Onsolis here