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FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain
Date:1/7/2011

e Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs  such as the program approved for Abstral.  FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.  

"This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs," added Dr. Jenkins. "When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS."

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain.  Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.  

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at http://www.fda.gov/MedWatch or by calling 800-332-1088.

Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.


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Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov


SOURCE U.S. Food and Drug Administration
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