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Brad Matthews


NextImg:Historic FDA approval marks first nonopioid breakthrough since Clinton era

The Food and Drug Administration announced Thursday its approval of suzetrigine, the first new painkiller greenlit by the agency since 1998.

Sold by Vertex Pharmaceuticals in 50-milligram tablets as Journavx, suzetrigine is the first nonopioid painkiller to target pain-signaling pathways in the peripheral nervous system before those signals reach the brain, the FDA said.

The last painkiller OK’d by the FDA was Celebrex, a Cox-2 inhibitor, according to CNN. That category of nonsteroidal, anti-inflammatory drug works by targeting the body’s production of a chemical that causes pain.



Suzetrigine is intended to treat acute pain.

To test whether suzetrigine worked, the FDA looked at data from a pair of randomized, double-blind, placebo- and active-controlled trials. People who took the medicine had a statistically significant lower amount of pain compared with people who took the placebo.

The medicine was found after researchers learned of a Pakistani family of fire walkers who didn’t have a gene that caused pain signals to fire in their skin, thereby letting them walk on hot coals without their body recognizing it was in pain.

“They knew that they were on something hot; they knew they could feel the coals. So it’s not impacting the nerves that do heat and touch and stuff like that. It is just these pain-conducting nerves,” Vertex Pharmaceuticals Chief Operating Officer Stuart Arbuckle told CNN.

The FDA emphasized that suzetrigine “offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” referring to the addictive potential of opioid medicine.

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Around 80 million Americans are given medicine to treat moderate to severe acute pain each year, with 40 million prescribed opioids. Of those 40 million, nearly 10% will go on to use opioids long-term and about 85,000 patients will develop an opioid addiction each year, Vertex Pharmaceuticals said in a release.

• Brad Matthews can be reached at bmatthews@washingtontimes.com.