FDA Green Lights Vertex’s Journavx (suzetrigine), a Non-Opioid Option for Acute Pain

The FDA has approved Journavx (suzetrigine), a first-in-class, non-opioid treatment for adults experiencing moderate-to-severe acute pain. As an oral, selective NaV1.8 pain signal inhibitor, Journavx blocks pain at the source while avoiding the addictive risks associated with opioids.

Journavx will be priced at $15.50 per 50mg pill, making it a competitively priced option in the non-opioid pain management market.

Journavx enters a growing postoperative pain market, valued at approximately $36.53 billion in 2022, which is driven by increasing surgical procedures and heightened concerns over opioid dependency. The demand for effective non-opioid pain relief options is expected to rise steadily.

According to the National Institute on Drug Abuse (NIDA), nearly 85,000 people develop opioid use disorder each year after initially receiving opioids for pain relief.

Journavx is a non-opioid analgesic, meaning it relieves pain without acting on opioid receptors. Unlike NSAIDs such as ibuprofen and naproxen, it does not work by reducing inflammation.

Instead, Journavx selectively targets NaV1.8, a voltage-gated sodium channel found in pain-sensing neurons outside the brain, reducing pain signals before they reach the central nervous system (CNS).

The twice-daily oral medication has demonstrated effectiveness across a range of pain types, including post-surgical and injury-related pain.

Vertex CEO Reshma Kewalraman called the approval a major milestone in acute pain management, noting that Journavx is the first new class of pain medicine in more than two decades.

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Journavx was evaluated in multiple studies, including two pivotal trials in patients undergoing abdominoplasty and bunionectomy. In both randomized, double-blind, placebo- and active-controlled studies, Journavx demonstrated a statistically significant reduction in pain compared to placebo while maintaining a favorable safety profile.

Patients were also allowed to use ibuprofen as needed for additional pain relief, further supporting its effectiveness in real-world settings.

Patients reported common side effects such as itching, muscle spasms, increased creatine phosphokinase levels and rash.

The FDA has also noted that Journavx is contraindicated for use with strong CYP3A inhibitors.

Importantly, the data showed no evidence of addictive potential, positioning Journavx as a strong alternative to opioid-based pain management.

Additional studies are planned for lumbosacral radiculopathy (compression or irritation of nerve roots in the lumbosacral region), pending regulatory discussions, as Vertex aims to expand its role in pain management in both acute and chronic pain.

The company has also set its sights on broader applications of suzetrigine, with ongoing Phase III trials evaluating its use in chronic pain conditions such as painful diabetic peripheral neuropathy. Additional studies are planned for other forms of neuropathic pain.

Following the FDA’s approval of Journavx, Vertex’s stock closed at $461.68, reflecting a 5.3% rise from the previous close. Some analysts are projecting strong future sales for the drug, with some estimates reaching up to $10 billion in peak sales.