FDA Approves Vertex Pharmaceuticals’ First-in-Class Non-Opioid Journavx for Moderate-to-Severe Acute Pain

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The FDA has approved Vertex Pharmaceuticals’ Journavx (suzetrigine), a first-in-class, non-opioid pain signal inhibitor for adults with moderate-to-severe acute pain. According to the company, the treatment selectively targets NaV1.8 channels, offering effective pain relief without evidence of addictive potential, marking the first new class of acute pain medication approved in over 20 years.¹

“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, MD, CEO, president, Vertex, in a press release. “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.”

The approval was based on data from two Phase II randomized, double-blind, placebo-controlled trials involving patients experiencing acute pain after abdominoplasty or bunionectomy.²

A total of 303 patients were enrolled in the abdominoplasty trial and 274 in the bunionectomy trial. The primary endpoint was the time-weighted sum of the pain-intensity difference (SPID) over a 48-hour period. Secondary endpoints included the time-weighted SPID between Journavx and placebo over a 24-hour period and the percentages of participants with a reduction in pain of at least 30%, 50%, and 70%.

In the bunionectomy trial, 90.1% of patients completed the trial, while 81.5% of patients completed the abdominoplasty trial. Compared to placebo, the least-squares mean differences of pain reduction was 37.8 in abdominoplasty and 36.8 in bunionectomy, with a consistent effect over 48 hours.

Common adverse events (AEs) included nausea, headache, and constipation, with headache occurring in 14% of high-dose patients compared to 6% for placebo patients. No serious AEs were reported as a result of Journavx.

Despite the trial’s success, there were a number of limitations. including a predominantly female population, use of Journavx as monotherapy for settings in which multimodal analgesia is standard, and the absence of a direct comparison with hydrocodone bitartrate–acetaminophen. Phase III trials aim to further evaluate the treatment’s efficacy against standard analgesics. Measures such as staff training and a double-dummy design were implemented to minimize bias, though no assessment of participant blinding was conducted.²

According to Vertex, approximately 80 million people in the United States receive medicine as a result of acute pain annually. Nearly half are prescribed an opioid to manage their discomfort each year. However, it is not uncommon for these patients to experience opioid use disorder up to a year following treatment, with data showing that around 85,000 people in the United States will develop the condition annually. Currently, patients can be prescribed acetaminophen or nonsteroidal anti-inflammatory drugs as alternatives, but these may have limited efficacy, particularly for moderate-to-severe acute pain.³

“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, MD, MPH, associate physician in emergency Medicine and pain medicine, San Diego, Vertex acute pain steering committee member, in the press release. “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.”

References

1. Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain. Vertex. January 30, 2025. Accessed January 31, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class

2. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. The New England Journal of Medicine. Accessed January 31, 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2209870

3. The state of pain in America. Vertex. October 8, 2024. Accessed January 31, 2025. https://www.vrtx.com/stories/state-pain-america/