FDA Approves Cancer Pain Drug, Onsolis

Not all people with cancer experience pain, but many do and when the pain goes to the bones, it’s often very severe. Currently, treatment for severe cancer pain includes a combination of medications, with a breakthrough medication – often morphine – that is given in between regular doses of the regular pain killer or analgesic .

The FDA has just approved a new medication, Onsolis, to help manage that breakthrough pain. It’s a novel way of giving medication. Onsolis is an opioid called fentanyl , which is often given as a patch to help manage severe pain. Onsolis, on the other hand, is a medication that is put on the inside of your cheek and is absorbed through the mucous membranes.

This medication shouldn’t be given to just anyone though as it’s reserved for patients who are used to high doses of opiate medications (narcotics). If Onsolis is given to someone who isn’t used to high doses, he or she could experience difficulty breathing or death.

Because of the strength of the drug, Onsolis will only be available through a special program called the FOCUS program. According to the FDA :

As part of the REMS, Onsolis will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients’ homes.

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Image: BioDelivery Sciences International