The US Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ oral Journavx (suzetrigine) to treat adults with acute pain.

The FDA has approved the non-opioid, highly selective NaV1.8 pain signal inhibitor for administration twice daily.

Vertex is also exploring the potential of suzetrigine in treating peripheral neuropathic pain. The company's Phase III pivotal programme for patients with painful diabetic peripheral neuropathy is currently underway.

It plans to progress its pivotal programme evaluating the therapy for painful lumbosacral radiculopathy, pending regulatory discussions.

The therapy’s mechanism allows it to block pain signals at source - in the periphery, rather than in the brain.

In the US, the company has set Journavx’s wholesale acquisition cost at $15.50 per 50mg pill.

Vertex Pharmaceuticals president and CEO Reshma Kewalramani stated: “With the approval of Journavx, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

Journavx is generally well-tolerated and shows no signs of addictive potential. It is indicated for the management of all forms of moderate to severe acute pain.

Its approval marks a significant milestone in the treatment of acute pain, which affects 80 million Americans annually, with approximately 40 million opioids prescribed.

Almost 10% of individuals treated with opioids for acute pain may continue prolonged opioid use, and around 85,000 may develop opioid use disorder every year.

The development follows the company’s FDA approval for two cystic fibrosis treatments in December 2024

However, it is noteworthy that those therapies carry boxed warnings regarding the risk of drug-induced liver injury, including liver failure.