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REMS for 505(b)(2) products?

Camargo has been involved in the development of several opioids and is often contacted by new sponsors to develop alternate formulations. One question often brought up is: does a 505(b)(2) approved opioid require a REMS (Risk Evaluation and Mitigation Strategies — for more information on REMS see a previous posting)? The short answer is: of course it does since REMS affects all applications 505j, 505(b)(1) and 505(b)(2). Thus, the sponsor of an opioid must develop a REMS. As if that isn’t enough of a challenge, the FDA is requesting a single, class-wide REMS. FDA and industry have been working on a common REMS for extended release opioids for a couple of years. With the recent approval of ProStrakan‘s Abstral (fentanyl sublingual tablets), a 505(b)(2) application, the FDA announced the need for a shared REMS. The FDA is asking ProStrakan, Meda (Onsolis – fentanyl buccal soluble film, approved via 505(b)(2) in 2009), Cephalon (Fentora — fentanyl buccal tablet approved via 505(b)(2) in 2006 and Actiq — transmucosal fentanyl citrate) and Watson (new generic of Fentora approved this month) to all work together for a single REMS for transmucosal fentanyl products. Per John Jenkins, M.D., director of FDA’s Office of New Drugs, “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”