Specialist explains intrigue of new pain-relief drug

Dr. Brett Stacey’s enthusiasm was palpable, likely mirroring that of other pain-medicine specialists across the United States. A new compound, suzetrigine, just became the first nonopioid analgesic in 25 years to win the Food and Drug Administration’s approval.

“This is the first drug in my career that was developed this way, and that is effective and has few side effects,” said Stacey, a practitioner for nearly four decades. He is division chief of pain medicine and a professor of anesthesiology and pain medicine at the University of Washington School of Medicine.

The new drug acts in a novel way, by decreasing sensory nerves’ ability to transmit pain signals, well before those signals reach the brain. Opioids, by contrast, work by modifying the brain’s perception of pain signals.

“But opioids are also closely tied to emotion and reward, and they make you sleepy and slow your breathing,” said Stacey. “This new drug was designed to avoid those potential problems.”

For years, pain-medicine scientists have explored sodium channels as a target. In nerve cells, sodium channels are proteins that transmit electrical impulses throughout the body.  The achievement of suzetrigine’s creators, Stacey said, was to create a compound that affects only a subset of nerve cells, outside the brain.

“They’re mainly on sensory nerves that conduct signals that can communicate pain when they get to your brain. This drug decreases the signals right as they get to the spinal cord. So the pain signal doesn’t get to the brain to have to be modulated,” he said.

Suzetrigine’s effectiveness was established in two clinical trials of patients who had undergone surgery to repair a bunion or to remove excess abdominal skin and fat (tummy tuck). The drug, then called VX-548, was tested against placebo; additionally, patients in the trials also could use ibuprofen as needed for “rescue” pain medication. Both trials showed that VX-548 delivered statistically significant superior pain reduction of pain, compared with a placebo, and without any serious adverse effects.

Those findings aligned perfectly with the FDA’s long support of nonopioid analgesics and earned the drug’s manufacturer, Vertex Pharmaceuticals, an expedited review.

Today suzetrigine, in a 50-milligram oral tablet, is immediately available and can be prescribed for 14 days to relieve acute pain. In the U.S., the drug’s wholesale cost is $15.50 per pill, which translates to $31 per day, based on the recommended twice-daily dosage. Patients’ costs may vary based on insurance coverage and other factors.  

Clinical trials are underway that should offer more information about the drug’s safety and efficacy to treat longer-term pain.  

“I would bet that in a couple of years, we could sit down and have this conversation, and that either this medication or medication very much like this is now approved for some chronic pain conditions,” Stacey said last week. “But we're not there yet.”

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