The FDA has approved a risk evaluation and mitigation strategy for Cephalon's Fentora and Actiq drugs to manage breakthrough pain in opioid-tolerant patients with cancer, according to a Cephalon news release.
Under Cephalon's REMS, physicians who prescribe the drugs must complete an education module and knowledge assessment focused on safety information, such as appropriate patient selection.
The REMS begins enrollment in September. The FDA recently started requiring REMS for rapid-onset opioids to minimize risks of misuse, abuse and addiction.
Read the Cephalon release on its new safety strategy for pain drugs.
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