The US Food and Drug Administration has approved the use of a novel painkiller as an effective treatment for short-term moderate-to-severe pain in adults. It’s the first of a new class of analgesics to be approved in over 20 years, and, importantly, it isn’t addictive.
At the beginning of 2024, New Atlas covered the impressive results of Phase 3 clinical trials by Vertex Pharmaceuticals Inc. that evaluated the company's novel non-opioid pain medication. Armed with data showing that the drug was safe and effective, in mid-2024, Vertex sought approval for its use from the US Food and Drug Administration (FDA).
On the 30th of January 2025, the FDA approved 50-mg tablets of the novel painkiller, which will be sold as Journavx (generic name: suzetrigine), for the treatment of short-term moderate-to-severe pain in adults.
“Today’s 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 Reshma Kewalramani, CEO and President of Vertex. “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’s novelty lies in its mechanism of action. It selectively targets a sodium channel critical to pain signaling in the peripheral nervous system, inhibiting pain signals from being sent to the brain. Importantly, the medication is not an opioid, which means that medical professionals now have an alternative to treating acute pain that doesn’t require using a potentially addictive analgesic.
“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,” said Jessica Oswald, Associate Physician in Emergency Medicine and Pain Medicine in San Diego and member of Vertex’s Acute Pain Steering Committee. “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.”
It's clear that a big reason the FDA assigned Breakthrough Therapy, Fast Track and Priority Review designations to Vertex’s approval application was that the painkiller is not an opioid.
“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research (CDER). “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscores FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”
The FDA has approved twice-daily Journavx for adults with moderate-to-severe acute pain. Vertex has set the wholesale acquisition cost (WAC) of the medication, the price set by a pharmaceutical manufacturer in the US when selling to a wholesaler, at US$15.50 per 50-mg pill.
Vertex is currently undertaking Phase 3 trials to evaluate suzetrigine’s effectiveness in treating peripheral neuropathic pain in diabetic patients.
Sources: Vertex Pharmaceuticals, FDA
