Pain is an infamously difficult cancer symptom to treat. Even when potent pain relievers are used, waves of pain often flare up and break through the effects of the medication. This type of pain is known as breakthrough pain.
Now, doctors and patients have a new tool to help combat breakthrough pain. Recently, the U.S. Food and Drug Administration (FDA) approved a drug specifically designed to minimize breakthrough pain. This new drug, called Onsolis, is a potent medication that is part of a class of drugs known as opioid fentanyls. Onsolis is meant to be used in conjunction with other opioid medicines.
Onsolis is not a traditional prescription pill. Rather, it is administered through an absorbable film that is placed inside the mouth. Onsolis sticks to the side of the cheek, and the opioids transfer into the bloodstream from there.
Because of the high potency of Onsolis, the drug is only intended for cancer patients who are “opioid tolerant.” This typically means that tolerance to opioid drugs is reduced due to round the clock use of pain relievers.
The potential for misuse and abuse places additional caveats on Onsolis prescription approval. For example, the patient’s age must be 18 years or older. Additionally, Onsolis was only allowed approval with the inclusion of a Risk Evaluation and Mitigation Strategy (REMS). An REMS requires a drug to have heightened plan of action that reduces risks associated with the drug.
In the case of Onsolis, the REMS calls for restricted distribution through the FOCUS program. This means that only patients, pharmacies and prescribers who are registered with the program will be granted access to the drug.
The heightened measures of approval are intended to reduce the potential for drug abuse. The Onsolis box also includes a warning that states the drug should not be used for the management of traditional pain, or by patients that use opioids intermittently. For those that are not opioid tolerant, Onsolis has the potential to lead to overdose and death.