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SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.
The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.
“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” FDA Office of New Drugs director John Jenkins said.
The drug will have a Risk Evaluation and Mitigation Strategy, or REMS program, designed to minimize the risk of misuse, abuse, addiction and overdose, the FDA said.