Abstral fentanyl regulatory update

FDA approved a single REMS for the class of transmucosal immediate-release fentanyl pain drugs to reduce the risk of misuse, abuse, addiction and overdose. The shared REMS, which takes effect in March, will replace separate REMS that are in place for each product. It will require prescribers and pharmacies to enroll in the shared program to prescribe or dispense the drugs for outpatient use. Prescribers and pharmacies already enrolled in an individual REMS will automatically be transferred to the shared program.

FDA said this is the first approved shared REMS for a group of drugs in the opioid class. The agency is working with sponsors on a shared REMS for long-acting and extended-release opioids and said that development is "on track." In November, FDA asked for comments on a draft blueprint covering proposed prescriber information to be included in the REMS. ...