Article preview from "The Pink Sheet" November 25, 2008
Find out why Opioid drug sponsors may be asked to adhere to a single, class-wide Risk Evaluation and Mitigation Strategy, should FDA determine that it has the authority under the FDA Amendments Act of 2008 to require such action.
Article preview from "The Pink Sheet" November 25, 2008
REMS Pivotal To Embeda, Remoxy Approvals; FDA Wants Class-Wide Plan
Opioid drug sponsors may be asked to adhere to a single, class-wide Risk Evaluation and Mitigation Strategy, should FDA determine that it has the authority under the FDA Amendments Act of 2008 to require such action.
In an effort to manage the post-marketing safety issues with scheduled pain products, FDA says it would prefer to develop a single REMS program for all marketed and pending opioids, rather than approving individual post-marketing programs for each drug.
There is precedent for such a move. FDA required a REMS for all fluoroquinolone antibiotics, although that program includes only a Medication Guide. The agency is also considering a single REMS for erythropoietin products.
In coming to a decision on whether to require a blanket REMS for the opioid class, FDA said it "would consider whether the elements to assure safe use are unduly burdensome on patient access to the drug and/or the health care delivery system."
Remoxy, Embeda Prompt REMS Discussion
The development of a class-wide REMS for opioids was discussed during a two-day advisory committee meeting convened to determine the approvability of two pain products: Pain Therapeutics' Remoxy (an abuse-resistant form of oxycodone) and Alpharma's Embeda (an abuse-resistant form of morphine).
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