FDA Approves Onsolis for Breakthrough Pain Management

At the same time that the US FDA is busy considering banning both Darvon and hydrocodone, they have gone ahead and approved a Schedule II narcotic painkiller product meant to serve as a breakthrough painkiller—i.e. a drug that can help cancer patients deal with severe pain flare-ups in between normal, less severe bouts of pain.

What is the new product?

The new product is called Onsolis. The actual narcotic painkiller is NOT new—Onsolis uses the extremely potent painkiller fentanyl.

The FDA approved Onsolis with a " Risk Evaluation and Mitigation Strategy, or REMS", which is a "required plan for managing risks associated with a drug or biological product." Onsolis will join other long-acting and extended-release opioids with REMS status.

How does Onsolis work?

Onsolis delivers fentanyl by way of an absorbable film that sticks to the inside of the cheek. It's designed for cancer patients who already use painkillers around the clock, but that may need an additional dose of strong meds to control occasional pain flare-ups. These patients are already considered opioid-tolerant because of their constant use of various opioids.

How can patients obtain Onsolis?

Onsolis will only be available through a restricted distribution program called the FOCUS program, which requires program registration from prescribers, patients and pharmacies in order to prescribe, dispense, and receive Onsolis. This is on account of its REMS status.

Warnings from the FDA about Onsolis

"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," said a spokesman at 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."

External Links

You can read the FDA's statement on Onsolis HERE.
You can read more about REMS HERE

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