FDA Approves Cancer Breakthrough Pain Drug with Safeguards

The Food and Drug Administration has approved a new opiate drug for severe breakthrough cancer pain.  However, Onsolis® will only be available through a restricted distribution program.

As part of an FDA-required Risk Evaluation and Mitigation Strategy, or REMS, only health care providers, pharmacies, and patients registered with the FOCUS program will be able to prescribe, dispense, and use the medicine.

The FOCUS program will:

  • Provide training and educational materials to health care providers and pharmacists about the drug’s risks and appropriate uses.
  • Make a counseling call to patients to be sure they have receive proper education about the drug’s use.
  • Only allow prescriptions to be filled by pharmacies that send the drug directly to the patient’s home.

Onsolis delivers fentanyl through an absorbable film that sticks to the inside of the mouth.  It can only be prescribed for patients who are already taking another opiate medicine around the clock, considered tolerant to opiates and can safely take high doses of fentanyl.

The drug has a boxed warning that it should not be used for migraines, dental pain, or pain after surgery or by patients who only use it on an as-needed basis. It also warns that it must be kept out of the reach of children and not substituted for other fentanyl products.

Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER) said,

Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death. For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications.

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