FDA Approves First New Type of Painkiller in Decades

To treat acute pain, doctors in the U.S. commonly prescribe opioids: powerful painkillers with dangerous side effects including serious risk of addiction and overdose. Now, the U.S. Food and Drug Administration (FDA) has green-lighted a promising alternative: a new non-opioid pain medication.

The FDA has approved a new type of drug called suzetrigine, branded Journavx, to treat acute pain in adults without the risk of addiction. Suzetrigine represents the first new class of pain medicine approved by the agency in over two decades, as well as the first medication of its kind ever approved. The announcement marks a significant milestone in the development of safer pain management, as detailed in a statement the FDA released yesterday.

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” Jessica Oswald, a member of the Vertex Acute Pain Steering Committee, said in a Vertex statement. Vertex Pharmaceuticals is the Boston-based biotech company that developed the newly approved drug.

“I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed,” she added. Since 1999, hundreds of thousands of Americans have died from opioid overdose. Despite the epidemic, doctors in the U.S. dispensed 125 million opioid prescriptions in 2023 alone.

Opioids activate receptors in the brain to block pain signals and cause the release of endorphins—the body’s feel-good, natural painkillers—which is why we risk becoming addicted. Suzetrigine, on the other hand, selectively blocks sodium channels on pain-sensing neurons, preventing the pain signal from reaching the brain in the first place, and doesn’t give any opioid-like “high.” It’s described as an “effective” and “well-tolerated” drug, according to the Vertex statement.

“Right now all the evidence suggests this has no addiction potential at all,” said Richard Rosenquist of the Neurological Institute at the Cleveland Clinic, as reported by NBC News. “It’s no different than Tylenol or ibuprofen in terms of addiction potential.”

Terp Vairin, who participated in a 2023 clinical trial of the medicine after undergoing nose surgery, told Nature that she “felt very lucid” after taking the drug, and didn’t experience side effects linked to opioid medication like grogginess or nausea.

“Today’s approval is a historic milestone,” Reshma Kewalramani, Vertex CEO and president, said in the Vertex statement. “We have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

However, given the medication’s steep price—$15.50 per 50-milligram pill—it remains to be seen whether suzetrigine has the practical potential, in addition to the medical one, to truly become a widespread opioid alternative.