When the Food and Drug Administration (FDA) approved the new opioid medication, Onsolis, last summer, it did so with care. The potent fentanyl delivered through the mouth’s mucous membranes by way of a lozenge on a stick similar to a lollipop, is only approved to treat breakthrough pain in cancer patients 18 and older already receiving around-the-clock opioid treatment.

As with any opioids, which are known for their euphoric effects, fentanyl is easily abused and misused. To curtail the public health issue with opioids, Onsolis was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which requires the drug maker to submit a plan for managing risks associated with a drug or biologic product. The requirement of REMS for this different class of opioids that offer long-acting and extended-release medication was initiated by the FDA in February 2009.

Onsolis, like similar painkillers Actiq and Fentora, is only to be used by patients who have already built up a tolerance to opioids. If taken inappropriately, these potent drugs “can lead to overdose, sudden serious breathing difficulties, and death,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER). “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.”

One issue at stake is that similar drugs, such as Actiq and Fentora, have been marketed for unapproved use in the treatment of headaches, backaches and even injuries. This has had deadly consequences in patients who have not already built up a tolerance to opioids. Upon its approval, Onsalis received a black box warning stating the drug should not be used for the management of headaches, dental pain or postoperative pain, or by patients who use opioids intermittently or on an as-needed basis.

Any other opioids in this class will only be approved with a REMS, and others in the class will have to follow suit.  “The REMS for Onsolis was specifically tailored to that drug and should not be viewed as a model REMS for long-acting and extended-release opioid products,” said Douglas Throckmorton, M.D., deputy director of CDER. “Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection.”



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