FDA Approves Non-Opioid Painkiller Journavx to Combat Acute Pain Without Addiction Risk

The U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine), a newly developed non-opioid pain medication designed to treat moderate-to-severe acute pain in adults. Unlike opioids, Journavx does not pose a risk of addiction, making it a transformative step in pain management treatment.

Journavx, produced by Vertex Pharmaceuticals, works by inhibiting NaV1.8 pain signals in peripheral nerves before they reach the brain. It is the first drug approved in this new class of pain-relief medications. The FDA sees the approval of Journavx as a chance to reduce opioid use in treating acute pain, offering patients a safer alternative.

“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,” said Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

Tackling Acute Pain Without Opioid Risks

Acute pain is a widespread issue, affecting millions of Americans annually. More than 80 million patients are prescribed medication for moderate-to-severe acute pain each year, with around 40 million of those prescriptions being for opioids. While opioids are effective for pain relief, they carry significant risks of addiction and misuse. Approximately 10% of patients prescribed opioids for acute pain later experience long-term opioid use, with nearly 85,000 patients developing opioid use disorder every year.

“Current data suggest that many people who develop opioid use disorder were first exposed to opioids after a surgical procedure,” explained Dr. Charles Argoff, president of the American Academy of Pain Medicine, who assisted in the development of Journavx. "The fact that Journavx may be used instead of an opioid could result in a meaningful reduction in opioid abuse, misuse, and opioid use disorder.”

How Effective Is Journavx?

Vertex Pharmaceuticals conducted two large clinical trials to test Journavx’s effectiveness. Each trial included around 1,000 participants who were experiencing pain following bunion surgery or tummy tucks. Participants were randomly assigned to receive Journavx, a placebo, or a hydrocodone and acetaminophen combination previously marketed as Vicodin. Journavx produced a 50% reduction in pain after 48 hours, comparable to the hydrocodone/acetaminophen combination and significantly more effective than the placebo.

In another trial involving over 250 patients experiencing acute pain or post-surgical pain, participants received Journavx starting with an initial 100 mg dose followed by 50 mg doses every 12 hours for up to 14 days. At the end of the trial, 83.2% of participants rated the pain relief from Journavx as good, very good, or excellent.

“This medication significantly lessened acute pain intensity in the pain models studied,” said Dr. Argoff. “Now that it’s available to prescribe, we can evaluate its broader significance across other acute painful conditions.”

Potential Side Effects and Restrictions

Journavx was proven safe and well-tolerated during clinical trials, with the most common adverse side effects being itchiness, muscle spasms, and rashes. The FDA warns that Journavx should not be used by people taking strong CYP3A inhibitors, such as the antifungal ketoconazole or the antibiotic erythromycin. Additionally, it advises patients using Journavx to avoid grapefruit or grapefruit juice, as they may interfere with the drug’s effectiveness.

Emergency room physician Sergey Motov, MD, cautioned that assessing Journavx’s safety and effectiveness in real-world scenarios could take one to three years.

Cost and Accessibility

The wholesale cost for Journavx will be $15.50 per pill, making it more expensive than many opioid pain medications. The retail price and insurance coverage details remain uncertain, though Vertex has plans for a patient assistance program to help people who may have difficulty affording the drug.

Can Journavx Address Chronic Pain?

While Journavx has shown significant promise for acute pain relief, its effectiveness for chronic pain is less clear. A phase 2 trial assessing the drug’s efficacy in treating lumbosacral radiculopathy, a condition often linked to sciatica, showed that Journavx had only marginal efficacy compared to a placebo after 12 weeks. Chronic pain is often linked to long-term changes in the nervous system, making it persistent and more challenging to manage. Vertex plans to proceed with a phase 3 trial for chronic pain treatment but acknowledges the complexity involved in addressing such conditions.

Conclusion

The approval of Journavx represents a major advancement in acute pain management, offering a non-addictive alternative to opioids. While questions remain about its cost, accessibility, and long-term real-world applications, this new medication promises to significantly reduce reliance on opioids for patients experiencing moderate-to-severe acute pain. Journavx signals a hopeful step toward addressing the opioid epidemic while providing effective and safer options for pain relief.