New FDA-Approved Painkiller

The FDA Approves Journavx, a New Non-Opioid Painkiller

The Food and Drug Administration (FDA) has approved Journavx (suzetrigine), a new non-opioid painkiller that promises to be nonaddictive.

How It Works

Journavx is approved to treat moderate-to-severe acute pain in adults, such as pain following surgery or injury. Suzetrigine, the active ingredient in Journavx, belongs to a class of medications called NaV1.8 pain signal inhibitors. The drug works by blocking pain signals in peripheral nerves before they reach the brain. Unlike opioids, it doesn’t carry a risk of addiction.

Effectiveness

Vertex conducted two large clinical trials, each with approximately 1,000 patients who had pain from either bunion surgery or tummy tucks. Patients who got Journavx reported about a 50% reduction in their pain after 48 hours—similar to those who received the hydrocodone/acetaminophen combination and more effective than the placebo.

Side Effects

Journavx was generally safe and well tolerated in the clinical trials. The most common adverse reactions were itch, muscle spasms, and rash. According to the FDA, people taking strong CYP3A inhibitors—such as the antifungal ketoconazole or the antibiotic erythromycin—should not use Journavx. Additionally, people taking Journavx should avoid grapefruit and grapefruit juice as they can reduce its effectiveness.

Cost

The wholesale cost of the drug will be $15.50 per pill, but a retail price has not been announced. This will make it much more expensive than some opioid drugs. It’s not yet known if insurers will cover the drug, but Vertex has said it will have a patient assistance program for people who cannot afford it.

Chronic Pain

Vertex has also performed a phase 2 trial of Journavx for lumbosacral radiculopathy, which causes sciatica, but found that it was not much more effective than a placebo at reducing pain after 12 weeks. The company aims to proceed to a phase 3 trial.

Conclusion

Journavx, Vertex’s new non-opioid painkiller, is an alternative for managing moderate-to-severe acute pain without the risk of addiction. Clinical trials showed it provides similar pain relief to opioids, but with fewer side effects.

Frequently Asked Questions

Q: What is Journavx?
A: Journavx is a new non-opioid painkiller that has been approved by the FDA to treat moderate-to-severe acute pain in adults.

Q: How does Journavx work?
A: Journavx works by blocking pain signals in peripheral nerves before they reach the brain.

Q: Is Journavx addictive?
A: No, Journavx is not addictive.

Q: What are the side effects of Journavx?
A: The most common side effects of Journavx are itch, muscle spasms, and rash.

Q: How much does Journavx cost?
A: The wholesale cost of Journavx will be $15.50 per pill, but a retail price has not been announced.