FDA Approves the First Non-Opioid Pain Drug in 20 Years

In Jan. 30, the U.S. Food and Drug Administration (FDA) approved a new drug called suzetrigine to treat moderate-to-severe pain. The prescription pills, sold under the brand name Journavx and made by Vertex Pharmaceuticals, are taken twice a day and represent the first new class of pain medications in 20 years—and the first non-opioid painkiller since that class first appeared on the market in the 1980s.

While opioids are currently the most potent and effective way to control pain, they are associated with a significant risk of addiction, and have fueled an epidemic of addiction and overdose deaths in the U.S. in recent decades. From 1999 to 2017, deaths from overdose due to prescription opioids increased more than seven times, exposing a dire need for effective but nonaddictive ways to manage pain.

Here’s what to know about suzetrigine.

How suzetrigine works

One major conduit for pain transmission in the human body is through sodium channels. People have nine such sodium channels in the body, and different ones are active in different tissue types, including in the brain.

Suzetrigine relieves pain by controlling the flow of sodium in and out of cells, and it targets one sodium channel that is specific to pain neurons in tissues that are found throughout the body but not in the brain. The medication therefore avoids the addictive potential of opioids, which work by binding to opioid receptors throughout the central nervous system, in both the brain and spinal cord.

Finding the right sodium channel target, however, took decades of research, which was all the more challenging since sodium channels by definition work quickly—so their effects, and the effects of any compounds designed to control them, are hard to measure. Once researchers identified the specific sodium channel that was selectively active in pain nerves, called Nav 1.8, scientists at Vertex combed through libraries of compounds to find an effective inhibitor to block the opening of the channel. “We screened hundreds of thousands of compounds looking for the needle in the haystack that inhibited 1.8,” says Paul Negulescu, senior vice president at Vertex. Animal studies were encouraging, and the company launched human studies that were completed in early 2024. Vertex submitted a request for FDA approval in July.

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