Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program
This article was originally published in Pharmaceutical Approvals Monthly
Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.
You may also be interested in...
All metrics for assessing the effectiveness of the Risk Evaluation and Mitigation Strategy for long-acting/extended release opioids may not be in place when FDA approves REMS for individual products.
Cephalon’s Actiq and Fentora will undergo increased distribution restrictions after joining FDA’s class-wide REMS for transmucosal fentanyl drugs, but a shared system, one of the main tenets of the risk management plan, is still under development.
Two new drug approvals represent the latest innovations in the emerging area of breakthrough cancer pain, designed to ease intense, short-term waves of heightened suffering in patients who are already taking opioids for persistent background pain.