Sodium Channel Targeting: What the Latest FDA Non-Opioid Approval Reveals About the Next Big Thing in Pain Relief

Suzetrigine, a novel painkiller, has received approval from the US Food and Drug Administration (FDA) for short-term pain management, making it the first new pain drug to be approved in over two decades. What sets suzetrigine apart is its ability to selectively block sodium channels on pain-sensing nerve cells, providing opioid-level pain relief without the risks of addiction, sedation, or overdose. Pain specialists are applauding the approval, calling it a major step forward in the ongoing fight against the opioid crisis, which has resulted in a wave of overdoses and fatalities across the United States and beyond. The approval underscores the potential of targeting sodium channels—a strategy that had long eluded pharmaceutical developers.

Vertex Pharmaceuticals Eyes $12 Billion in Revenue for 2025, with Market Shifting Focus on Non-Opioid Pain Treatment Journavx

Following its FDA approval, Suzetrigine became the first new painkiller introduced in two decades, offering a promising alternative to traditional opioid treatments. This approval comes as part of a broader strategy by Vertex Pharmaceuticals (NASDAQ: VRTX) to expand its portfolio with innovative therapies. In addition to Suzetrigine, the company has made strides with its gene therapy, Casgevy, for sickle cell disease, and Alyftrek, its fifth cystic fibrosis treatment. Another major milestone for Vertex is the recent FDA approval of Journavx, a non-opioid pain relief medication. During their quarterly earnings presentation on Monday, Vertex executives detailed their plans for these products, emphasizing a strategic shift towards non-opioid treatments to address the growing demand for alternatives in pain management.

Now it is apparent that Journavx, which Vertex plans to begin shipping by the end of this month, is already making waves in the pain relief market. Initially, Vertex is focusing on securing broad stocking agreements with national and regional pharmacy chains to ensure widespread availability. However, the company faces a significant challenge in terms of access, as the price of Journavx is steep compared to generic opioids. The company plans to charge $15.50 for a 50 mg dose, which amounts to $420 for a two-week course of treatment. In contrast, generic opioids cost roughly $0.50 per pill.

Despite the higher price tag, Vertex remains optimistic about Journavx’s market potential. The company is closely monitoring public policy efforts aimed at increasing access to non-opioid treatments, such as the recently passed Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act. The NOPAIN Act, which came into effect at the beginning of this year, expands access to non-opioid pain management options in hospital settings for Medicare enrollees. Vertex expects Journavx to be included in this legislation, which could help drive demand. Additionally, the Alternatives to Pain Act has been reintroduced in the Senate, which would ensure that Medicare Part D recipients, who number approximately 52 million seniors, would pay the same out-of-pocket cost for non-opioid treatments as they would for opioids. Vertex views this legislation as a key step in leveling the playing field for non-opioid pain treatments, including Journavx.

To support these efforts, Vertex is leveraging its 150-person sales force, which is actively engaging with healthcare providers and physicians to share the promising safety and efficacy data for Journavx. In particular, Vertex is focusing on high-volume hospitals, with plans to engage roughly 2,000 such institutions as well as approximately 150 related health systems. Stuart Arbuckle, Vertex’s Chief Operating Officer, emphasized that initial use of Journavx will likely target patients recovering from surgery, where doctors are most concerned about the risks of opioid prescriptions.

Vertex Reports Strong Q4 Results, Projects $12 Billion in 2025 Revenue

In the fourth quarter, Vertex reported $2.91 billion in revenue, marking a 16% year-over-year increase and surpassing consensus estimates by 5%. The strong performance was driven primarily by its cystic fibrosis blockbuster, Trikafta, which generated $2.91 billion in product revenue. Additionally, the company’s gene therapy Casgevy earned $8 million. For the full year, Vertex saw a 12% revenue growth, reaching $11.02 billion. Looking ahead, Vertex projects total revenue between $11.75 billion and $12 billion for 2025, a forecast that Evercore ISI deems “likely conservative,” as the company expects continued growth from both existing and new products.

Market analysts have weighed in on the drug’s prospects. Citi analysts project that Journavx could generate $110 million in sales this year. Meanwhile, Evercore ISI analysts anticipate that the drug will likely be added to the NOPAIN Act soon but caution that initial sales may be slower as Vertex works to gain approval from hospital formulary managers. Analysts also suggest that Vertex’s strategy of focusing on post-surgical pain relief will be key to the drug’s early success.

Suzetrigine: A Game-Changer in Pain Relief Without the Opioid Risks

Marketed under the name Journavx, suzetrigine is the first pain drug to be approved in over 20 years that works through a completely new mechanism. Unlike opioids, which have been widely associated with addiction, overdose, and death, suzetrigine offers a safer alternative by selectively blocking sodium channels on pain-sensing neurons, delivering potent pain relief without the typical risks. Pain specialists are applauding the breakthrough, which could potentially save thousands of lives and reduce the opioid crisis that has gripped the United States for years.

Stephen Waxman, a neuroscientist at Yale School of Medicine, calls this a significant step forward, while anaesthesiologist Paul White, involved in suzetrigine’s development, notes that anything that can reduce opioid dependency is a “significant positive.”

Suzetrigine’s Advantage Lies in Its Side Effect Profile, Not Just Efficacy, with No Addiction Risk

Vertex’s suzetrigine is being hailed as a major breakthrough in the treatment of acute pain. The drug works by selectively blocking the sodium channel NaV1.8, which plays a key role in both acute inflammatory pain and neuropathic pain caused by nerve damage. Dr. Steven Cohen, professor of anesthesiology and pain medicine at Northwestern University Feinberg School of Medicine, emphasized the significance of the drug’s side effect profile. “The advantage of suzetrigine is not its efficacy, but rather its side effect profile, including the absence of addiction potential,” Cohen stated.

Although suzetrigine’s approval is limited to acute pain and does not extend to chronic pain treatment, Cohen views this as a step forward in pain management. “The approval will hopefully open the door for more non-opioid treatments for both acute and chronic pain, including those that target other sodium channels,” he said.

Targeting NaV1.7, NaV1.8, and NaV1.9: Pain Relief Without the Risk to Heart and Brain

Suzetrigine’s success didn’t come easily. It’s the result of decades of research aimed at making pain relief safer and more effective. Sodium channels, which play a crucial role in transmitting pain signals through nerve cells, come in nine distinct subtypes. Previous drugs that targeted these channels indiscriminately led to severe side effects, limiting their effectiveness.

Researchers discovered that three subtypes—NaV1.7, NaV1.8, and NaV1.9—were predominantly found in pain-sensing neurons, meaning they had minimal activity in vital organs like the heart and brain. Targeting these specific channels promised powerful pain relief without significant side effects.  The search for a sodium-channel-targeting drug initially focused on NaV1.7, which was identified as a key regulator of pain perception. But after disappointing results, attention shifted to NaV1.8, which led to the development of suzetrigine. Suzetrigine is more than 30,000 times more potent at blocking NaV1.8 compared to other sodium channelsmarking a major victory in the search for a safer painkiller.

For drug developers, suzetrigine’s approval is a landmark moment, proving that targeting sodium channels is a viable strategy for pain management. “VX-548 didn’t come out of nowhere,” says Marc Rogers, a drug-discovery consultant in the UK. “It’s a story of long, hard work.”

As suzetrigine enters the market, it brings hope for those suffering from chronic pain, offering a promising new option that could help reduce reliance on opioids and minimize the risks associated with current treatments.

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Author

Bernice Lottering