Nonopioid Pain Drug Journavx Gaining Traction With High Potential

Vertex Pharmaceuticals’ newly approved nonopioid drug, Journavx (suzetrigine), offers a promising alternative to traditional opioids at a time when nearly 40 million patients are being prescribed opioid medications annually for moderate-to-severe acute pain.

After its FDA approval in January, Journavx has garnered much attention for its potential to reshape pain management and reduce opioid reliance.

Unfortunately, nearly 10% of patients initially treated with opioids develop prolonged use, and approximately 85,000 people each year develop opioid use disorder, leading to 14,716 deaths counted in 2022.

As the first new class of pain medication approved in over two decades, Journavx is designed to treat moderate-to-severe acute pain in adults.

By targeting the NaV1.8 pain-signaling receptor, it blocks pain signals from reaching the brain, providing an effective, non-addictive alternative to opioids.

According to a Vertex spokesperson, the drug is seeing strong initial market adoption, with growing payer coverage and ongoing clinical studies aimed at expanding its use beyond acute pain management.

“The response has been overwhelmingly positive, which we believe speaks to the clinical profile of Journavx and the significant unmet need in moderate-to-severe acute pain,” the spokesperson said. “(The drug) is now available and stocked in retail pharmacies across the U.S., and patients are receiving and filling prescriptions.”

Related: Is Journavx a Step Forward In Pain Management or a Repeat of Past Mistakes?

The spokesperson confirmed that the drug remains at a wholesale price of $15.50 per 50 mg pill.

Announced in Optum Rx’s Formulary Update in February, Journavx has been placed on tier 3 of the company’s premium and select formularies and is being further evaluated by the Optum Rx National Pharmacy & Therapeutics Committee to evaluate its cost and safety.

According to UnitedHealthcare, the health benefit business of UnitedHealth Group, a tier 3 designation means the highest-costing drugs.

David Calabrese, M.H.P., chief clinical officer of pharmacy care services at OptumRx and a member of Managed Healthcare Executive's editorial advisory board, told MHE editors that the committee will make a recommendation on formulary placement soon.

As demand for nonopioid alternatives grows, Journavx’s clinical data and ongoing research follow suit.

In fact, its approval was based on two randomized, double-blind, placebo- and active-controlled phase 3 clinical trials, which demonstrated significant pain reduction compared to placebo 14 days after patient operations.

One trial focused on patients recovering from abdominoplasty, while the other involved those undergoing bunionectomy.

To further evaluate its safety and effectiveness, Vertex has launched two phase 4 studies.

The first study will examine its role in managing pain following orthopedic, abdominal and gynecological surgeries as part of standardized perioperative multimodal pain management regimens.

The second will evaluate its use in aesthetic and reconstructive plastic surgeries under real-world perioperative pain management settings.

While they are not yet recruiting, both studies are expected to begin at the end of March and conclude by January 2026.

Beyond acute pain management, Vertex is exploring Journavx’s potential in treating neuropathic pain.

Peripheral neuropathic pain (PNP), which includes painful diabetic peripheral neuropathy (DPN) and painful lumbosacral radiculopathy (LSR), presents a higher risk of opioid use.

Journavx is currently in phase 3 trials for DPN, evaluating both its tolerability and efficacy, as well as its long-term safety for painful DPN, with completion expected by early 2027.

The spokesperson added that securing further insurance coverage for Journavx remains a key focus.

Seven state Medicaid plans, including New York and Arkansas, now cover Journavx without requiring prior authorization, they added.

Discussions with commercial and government payers are ongoing, and further adoption is anticipated as more data becomes available.

As insurers and healthcare providers examine the drug’s value, industry experts are watching how payers manage access to Journavx.

Jeffrey Casberg, M.S., R.Ph., a senior vice president of clinical pharmacy at IPD Analytics and a member of MHE's editorial advisory board, noted in a recent interview with Managed Healthcare Executive that he expects 2025 to be a pivotal year for the drug’s market positioning.

“Everybody in 2025 will be looking at and deciding how to manage (Journavx),” he said. “A lot of people are looking at these pain management drugs. In fact, many states are implementing laws to avoid step therapy of opioids before nonopioids.”

Journavx’s financial projections further highlight its market potential.

According to an analyst report from Visible Alpha, the projected sales for Journavx could be $105.8 million in 2025, rising to $362 million in 2026, with peak global sales of $2.6 billion by 2032.

Once the drug secures additional regulatory approvals for DPN and other neuropathic pain indications, total sales across acute and chronic pain could reach $3.4 billion in the next 7 years, accounting for 15% of Vertex’s total revenue.

In 2024, Vertex reported full-year earnings of $11.02 billion.

When considering the investment potential of Vertex stock, AIInvest reported that the FDA approval of Journavx is expected to significantly impact Vertex Pharmaceuticals' financial projections over the next five years.

The report banks on the drug having the potential to become a blockbuster drug, with projected annual sales exceeding $1 billion due to its unique mechanism of action and ability to serve as a non-addictive alternative to opioids.

Its approval opens the doors for Vertex to expand beyond its core cystic fibrosis portfolio and establish a presence in the highly competitive acute pain market.

However, the report notes that several challenges remain, including regulatory uncertainties that could delay new indications, competition from other pharmaceutical companies developing similar non-opioid pain treatments and concerns over pricing and reimbursement, which may affect payer adoption and market access.