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

SILVER SPRING, Md., Jan. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.  Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

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"This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain," said John Jenkins, M.D., director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine.  Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient's normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use.  Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.  

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose.  Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product.  FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, th
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SOURCE U.S. Food and Drug Administration
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