FDA achieves part of its 'class wide' REMS for immediate-release fentanyl

January 6, 2012
Pharmaceutical Commerce, Pharmaceutical Commerce - January/February 2012,

Manufacturers will share a common access program

First there were

html">REMS (Risk Evaluation and Mitigation Strategies)—post-approval requirements of manufacturers to more closely monitor how their products are used, and to report results back to FDA. Then came a proposed “class wide” REMS for all extended-release opioid drugs, which was stymied by an FDA review panel’s own

id_REMS.html">rejection of a fairly innocuous medication-guide requirement in favor of something more restrictive. Now, while noting that “We are continuing to work on another class REMS for the class of long-acting and extended-release opioids,” FDA has issued a “shared REMS” for transmucosal immediate-release fentanyl (TIRF). This will involve Cephalon (makers of Actiq and Fentora), Meda Pharmaceuticals (Onsolis), Archimedes Pharma (Lazanda) and Prostrakan (Abstral). All these drugs are either buccal formulations or nasal sprays.

According to FDA, one of the main drivers of the shared-access service is to simplify certification and reporting requirements of healthcare providers. Everyone (patients, prescribers, pharmacies and distributors) currently enrolled in the existing REMS programs of these drugs will automatically be included in the new program, to be accessed at www.TIRFremsaccess.com. Hospitals providing these drugs in an in-patient setting are excluded. Under the existing REMS, prescribers need to enroll, participate in an educational program, and complete a “knowledge assessment,” while maintaining records on outcomes for patients.

The system is scheduled to go live in March.