The U.S. Food and Drug Administration has approved a new non-opioid painkiller for adults experiencing short-term pain, marking the first approval of its kind in more than two decades.

The drug, suzetrigine—marketed under the brand name Journavx—blocks pain signals before they reach the brain, according to its manufacturer, Vertex Pharmaceuticals. The company says the drug provides effective relief for moderate to severe pain without “the addictive potential of opioids.”

The approval comes as the U.S. continues to grapple with an opioid crisis that has claimed tens of thousands of lives each year. In 2022, more than 82,000 opioid-related overdose deaths were reported, according to the Centers for Disease Control and Prevention.

The FDA said clinical trials showed that Journavx reduced pain after surgery and called its approval “an important public health milestone in acute pain management.”

A new approach to pain relief

Opioids work by stimulating receptors in the brain, blocking pain signals while triggering the release of dopamine, a neurotransmitter associated with pleasure and reward. This process makes opioids highly addictive.

Vertex estimates that nearly 10% of patients initially prescribed opioids for acute pain go on to develop prolonged opioid use.

Journavx, however, functions differently by preventing pain signals from reaching the brain in the first place. The company says this mechanism makes it a promising alternative for millions of patients who require short-term pain relief.

“This approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Vertex CEO Reshma Kewalramani.

The drug will cost $15.50 per capsule, the company said. It is not yet known whether Journavx is safe or effective for children.

The opioid crisis and policy response

The opioid epidemic has been a major public health issue in the U.S. for years. In 2017, then-President Donald Trump called it a “national shame” and declared a public health emergency.

Now in his second term, Trump has proposed a 25% border tax on imports from Canada and Mexico, partly in response to the flow of fentanyl—a potent synthetic opioid—into the country. He has also threatened tariffs on China, citing its role in fentanyl exports.