The drug suzetrigine, known by its brand name Journavx, works by targeting pain signals before they reach the brain.

Its manufacturer Vertex Pharmaceuticals said this enables it to provide effective relief for moderate to severe pain without “the addictive potential of opioids”.

The US has been grappling with a painkiller-addiction crisis for years. In 2017 US President Trump called it a “national shame” and declared a public health emergency .

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

Every year, tens of thousands of Americans die from opioid use, with 82,000 opioid-involved overdose deaths in 2022, according to the US Center for Disease Control and Prevention (CDC).

Now in his second term, President Trump has said he will hit imports from Canada and Mexico with 25% border taxes in part to address the large amounts of fentanyl – a powerful synthetic opioid – crossing into the country.

The president has also threatened to impose tariffs on China, citing the country’s fentanyl exports as a reason.

Opioids work by stimulating opioid receptors in the brain, blocking pain signals.

During the process, the brain also floods with the neurotransmitter dopamine, creating feelings of euphoria and activating the brain’s reward system.

This makes opioids highly addictive. Vertex estimates nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use.

But Journavx works in a different way,by blocking pain signals before they reach the brain.

Vertex says the drug is the first in a new class of pain medicine to be approved in more than 20 years.

Its chief executive Reshma Kewalramani called the approval an “historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year”.

Journavx will cost $15.50 (£12.50) per capsule, the company said, adding it is not yet known whether the drug “is safe and effective in children”.