FDA approves non-opioid painkiller Journavx

The Food and Drug Administration on Thursday approved Journavx, a non-opioid painkiller that is the first novel pain drug to win government authorization in more than 20 years.

Vertex Pharmaceuticals, which makes the drug, has billed it as an effective alternative to opioids that isn’t addictive. Journavx works by intercepting pain signals before they reach the spinal cord, rather than acting directly on the brain. Vertex said the wholesale cost would be $15.50 per 50 milligram pill, or about $31 for a recommended starting dose.

“Today’s approval is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement late Thursday. Corrigan-Curay emphasized that Journavx could “mitigate certain risks associated with using an opioid for pain.”

The news release issued by the FDA is notable because the Trump administration last week instructed federal health agencies to pause all external communications, such as releases, social media posts and website updates. Stefanie Spear, a Department of Health and Human Services spokeswoman and longtime ally of Robert F. Kennedy Jr., told The Washington Post that exceptions would be made for announcements believed to be “mission critical, but they will be made on a case-by-case basis.”

The FDA’s official account on X also tweeted the news—the agency’s first post since President Donald Trump was inaugurated.

Though the agency approved the drug to treat acute, short-term pain, Vertex is running clinical trials with the aim of expanding its use to chronic pain.

“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,” Reshma Kewalramani, Vertex’s chief executive, said in a statement. Kewalramani cast the moment as an “opportunity to change the paradigm of acute pain management and establish a new standard of care.”

Still, Journavx faces some hurdles in winning over physicians, hospitals and insurance companies. It is a brand-name drug competing with cheap, generic opioids that remain among the most effective painkillers on the market.

And while Vertex has produced compelling proof of the drug’s effectiveness in highly controlled clinical settings, analysts say the real-world impacts—such as reducing how long patients stay in hospitals, or curbing opioid addiction—will only become clear after the drug’s launch.

Wall Street analysts expect that Journavx, whose active ingredient is suzetrigine, could bring in about $100 million in sales this year.

“We believe the opioid epidemic could be a priority for policy,” Geoffrey Meacham, an analyst for Citi Research, wrote in a note to clients on Thursday, citing Kennedy’s confirmation hearing earlier in the day. “We are excited for the potential disruption of the pain treatment landscape,” he wrote.

The FDA’s approval is based on clinical trials in people recovering from two types of surgeries—tummy tucks and surgical bunion removals—that showed suzetrigine meaningfully reduced pain for participants. Strikingly, patients who took the drug had a lower rate of bad reactions such as nausea, headache and constipation than those who were given a placebo.

For decades, the nation has been in the midst of a staggering overdose crisis that in 2023 killed more than 100,000 people for the third year in a row. However, recent data has shown overdose deaths declining, a sign that some efforts to combat the crisis have been working.

“This is like no other medicine I’ve ever launched, and I’ve been doing this 40 years,” Stuart Arbuckle, Vertex’s chief operating officer, said in an interview ahead of the announcement. “Just about every part of the health-care system has borne some responsibility for the size of the opioid epidemic,” he added. The effectiveness and safety profile of Journavx, he said, “is something everyone is excited about.”

Not everyone is convinced that Journavx will have a transformative impact on treating pain. Results from a trial on sciatica failed to show an advantage over a placebo, cooling analysts’ expectations on the drug’s potential for some types of chronic pain.

The Institute for Clinical and Economic Review, an influential nonprofit that analyzes the cost-effectiveness of prescription drugs, wrote in a draft report in December that suzetrigine would be “slightly cost-saving” compared to an opioid combination if it cost $420 a week. The savings are largely based on estimates of how much the drug could avert cases of people becoming addicted to opioids.

The number of people who develop opioid-use disorder after receiving a short-term opioid prescription remains a subject of debate, with some scholars suggesting that it is only a small fraction of patients.

Vertex has estimated that about 85,000 people a year are diagnosed with opioid addiction within a year of being prescribed an opioid for acute pain.

Journavx was approved to treat moderate to severe acute pain in adults, and it is not known whether the drug is safe and effective in children, the company noted.