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Pain drug approved under new REMS

ProStraken's Abstral for breakthrough cancer pain has been granted US approval under a new kind of risk evaluation and mitigation strategy

The US Food and Drug Administration (FDA) has granted marketing approval to ProStraken's Abstral (fentanyl) transmucosal tablets for breakthrough cancer pain under a new kind of risk evaluation and mitigation strategy (REMS). The new strategy is designed to standardise key components of the programme to make a single shared system possible for all immediate-release fentanyl products.

"This approval is a significant step toward reducing the burden on the healthcare system of implementing REMS programmes," said John Jenkins, director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is an immediate-release tablet that dissolves and is absorbed through the inside of the cheek, gums, tongue, nasal passage or throat. The drug has been approved for use in patients aged 18 years and older who already use opioid pain medication around the clock but who need high doses of an additional opioid medicine for breakthrough pain that comes on suddenly for short periods of time.

The marketing application for Abstral was based on a small (roughly 300-subject) safety study of cancer patients who took the drug for an average of 131 days.

Under the REMS for Abstral, pharmacies, distributors, and healthcare professionals who prescribe the drug to outpatients are required to register and to follow certain regulations. Newly standardised components of the REMS include the REMS document, the patient-prescriber agreement, and the enrolment form, which can be used by all sponsors of immediate-release transmucosal fentanyl products.

The sponsors of the various marketed immediate-release products have also been instructed by the FDA to work together on a shared system for implementing the REMS. "When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardised materials and a single shared system to implement the REMS," Jenkins said.

10th January 2011

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