FDA approves opioid analgesic for cancer-related pain management

The FDA has approved fentanyl immediate-release transmucosal tablets to help manage breakthrough pain in adults with cancer.

The drug (Abstral, ProStraken Inc.) is intended for patients aged 18 years or older who have cancer and already use opioid pain medication but need and are able to use high doses of additional opioid medication. It is administered on the inside of the cheek, gums, tongue, nasal passages or throat where it dissolves and is absorbed.

According to an FDA press release, only health care professionals trained in the use of schedule II opioids for the treatment of pain should prescribe fentanyl. In addition, the drug is only available through the Risk Evaluation and Mitigation Strategy (REMS) program, which requires pharmacies, distributors and health care professionals to enroll before prescribing, dispensing and distributing such products to outpatients. The system is designed to minimize the risk for misuse, abuse, addiction and overdose.

In an effort to promote the adoption of a shared system, the FDA has standardized the REMS document, the Patient-Prescriber Agreement and the REMS enrollment form. All sponsors of immediate-release transmucosal fentanyl products can use these components of REMS to develop individual programs; sponsors of this class of products have been directed by the FDA to work together to develop a shared system to implement the REMS.

“This is an important step for patients with cancer to have options for the treatment of their breakthrough pain,” John Jenkins, MD, director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research, said in a press release. “This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” he said. “When fully implemented, FDA expects that prescribers, pharmacies and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials to work together on a single shared system to implement the REMS.”

Two-hundred and seven of 311 opioid-tolerant patients with breakthrough pain were treated in multiple-dose studies, with duration of therapy ranging from 1 to 405 days with an average duration of 131 days. Forty-four patients were treated for at least one year.

Nausea, constipation, drowsiness and headache were the most common adverse events. More serious events, including death, have been reported in patients with other immediate-release transmucosal fentanyl products and occurred as a result of improper patient selection or improper dosing.

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