Boston: A long-awaited nonopioid pain drug won approval yesterday from the U.S. Food and Drug Administration (FDA) to treat moderate to severe short-term pain. Suzetrigine, an oral drug marketed by Vertex Pharmaceuticals as Journavx, is the first to reach the market in a new class of pain treatments that avoid risks such as slowed breathing and the potential for addiction that come with opioid drugs such as oxycodone.
Rather than dulling pain by targeting the brain’s opioid receptors, suzetrigine works by blocking a sodium channel called Nav1.8 on pain-sensing nerves. Its development grew out of the discovery that people with genetic mutations that increase the channel’s activity suffered nerve pain even in the absence of injury.
Vertex announced last year that suzetrigine outperformed a placebo in its two pivotal trials, which involved people with pain after surgeries to remove bunions and excess abdominal fat. FDA has cleared the drug specifically for use in acute pain conditions, such as those after tissue injury from surgery or trauma.
Many in the field hope suzetrigine will also prove effective against harder to manage chronic pain conditions. But results Vertex announced last month from a phase 2 study, in people with the painful nerve condition lumbosacral radiculopathy, left some doubt. The study showed a reduction in pain among 102 people getting the drug, but also a similar pain reduction in 100 people who got a placebo. The company said it plans to proceed with a phase 3 trial designed to better control for the placebo effect, “pending discussions with regulators.”
