FDA Approves First Drug in New Class for Pain Relief

New Non-Opioid Therapy Approved for Acute Pain

Introduction:

On January 30th, 2025, the Food and Drug Administration (FDA) announced the approval of a new pain medication called Journavx™. It was approved to treat moderate to severe acute pain in adults. Acute pain is new pain caused by an event such as an injury, illness, surgery, etc. Acute pain does not last long and will usually subside if the underlying cause has been treated.

New Product Details

• Medication name: Journavx™ is the brand name of this newly approved medication.
• Active Ingredient and Strength: Suzetrigine 50 mg (milligram) oral tablets.
• Anticipated Availability: First or second quarter of 2025 (exact date unknown).
• Price: Starting at $ 18.60 (average wholesale price) per tablet.
• Directions for Use: One tablet (50 mg) orally every twelve hours for pain (after initial larger 100 mg starter dose).
• Advantage: This is the first medication approved in a new class of medications with a novel mechanism of action. As a non-opioid medication, it does not carry the same adverse effects or addiction warnings. Journavx can be used as an alternative to opioids to treat certain types of acute pain.
• Side effects: Common side effects include muscle spasms, itching, rash, and increased blood levels of creatine phosphokinase.
• Drug interactions: Journavx™ is contraindicated with concomitant use of CYP3A inhibitors (e.g., some antivirals and antibiotics, amiodarone, clobazapam, phenobarbital, etc.).

Relevance to Injury Claims

Pain management remains one of the most frequently visited treatment specialties regarding workers’ compensation injury claims. There is a constant demand for non-opioid pain management therapies. Opioids are one of the most dangerous medication classes. They have serious risks of misuse, diversion, and adverse effects. They can even cause accidental overdose and in some cases death. While not yet approved for chronic pain, professionals can expect this medication to treat injured workers with acute pain.

Clinical Team Input

Journavx™ represents an exciting new treatment option for patients with acute pain. It is not yet FDA-approved to treat chronic pain, but that use is being studied in clinical trials by the drug manufacturer. This medication works by blocking pain signals through special sodium channels in the peripheral nervous system before they reach the brain. This contrasts with other pain medications such as opioids that work on receptors in the brain to block the perception of pain. With less expected side effects and no known addictive properties, this medication will likely spark considerable interest. The high cost may be a prohibitive factor however.

Efficacy was assessed through two double-blind, randomized, placebo and active controlled clinical trials. They evaluated relief of acute surgical pain following either a bunionectomy or abdominoplasty. All participants were also allowed to use Ibuprofen as needed for breakthrough pain. Each trial showed a statistically significant superior reduction in pain compared to the placebo.

CorVel Response

We will continue to monitor the release of novel medication formulations, new generic medication launches, and new drug developments that are applicable to the injury claim industry. As we monitor these new developments, we will act as appropriate and necessary. Examples include clinical reporting, formulary updates, outreach, and industry update publications.

The cost of this new medication is higher than older, generic pain medications (including opioids). New, brand-only medications are typically more costly than older, generic alternatives.

For more information, review the FDA’s announcement available at:

https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

For any specific information about Journavx itself, review the prescribing information available at:

https://pi.vrtx.com/files/uspi_suzetrigine.pdf