FDA Approves First New Painkiller in 25 Years: Journavx Offers Non-Opioid Alternative for Acute Pain

For decades, Americans seeking relief from pain have faced limited options: over-the-counter medications like ibuprofen, which often provided minimal comfort, or prescription opioids that come with the risk of addiction and overdose.

That has now changed. The U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Suzetrigine, commercially known as Journavx, a non-addictive prescription painkiller for managing acute pain following surgeries or injuries. Administered twice-daily, Journavx represents the first new pain management option approved by the FDA in a quarter-century.

Implications for the Opioid Crisis

Local medical professionals and treatment experts believe that Journavx could be a significant tool in combating the opioid crisis on Long Island. The introduction of this medication provides a pain management solution without the addictive properties of opioids like Vicodin or OxyContin.

However, Journavx has its limitations. Currently, it is only approved for acute rather than chronic pain. Additionally, its cost—$15.50 per 50 mg pill—may be a barrier for some patients.

Adam Birkenstock, director of programming at the Long Island Council on Alcoholism & Drug Dependence in Westbury, underscores the importance of new pain management options. “While it’s promising, these treatments must be both affordable and accessible to prevent more individuals from falling through the cracks,” he stressed.

How Effective Is Journavx?

The FDA approved Journavx based on two clinical trials involving 874 participants with moderate to severe acute pain from procedures such as tummy tucks or bunion removal surgeries. Participants received either Journavx, a placebo, or Vicodin. Journavx delivered comparable pain relief to Vicodin, reducing pain levels by an average of three points on a 10-point scale. Importantly, Journavx worked more swiftly and with fewer side effects.

In her statement, Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, hailed the approval as a “public health milestone” in acute pain management.

Vertex, the manufacturer, noted that the most common side effects of Journavx included itching, muscle spasms, increased levels of creatine phosphokinase in the blood, and rash.

“This is an opportunity to redefine how we approach acute pain treatment, potentially setting a new standard of care,” stated Dr. Reshma Kewalramani, CEO and president of Vertex.

Beyond Acute Pain

While Journavx is specifically designed for acute pain, Vertex Pharmaceuticals is exploring its efficacy in chronic pain conditions as well. Chronic pain management remains a critical need, as the opioid epidemic has taken a severe toll, particularly on Long Island.

According to local data, fatal overdoses on Long Island decreased in 2023, with Suffolk County reporting a 11% decline from 524 in 2022 to 463 in 2023. Nassau County similarly saw an 16% reduction, with 210 deaths in 2023 compared to 250 in 2022.

“Giving people who are at risk of opioid addiction a non-opioid option can make a significant difference,” observed Dr. Manassa Hany, Northwell Health’s division director for substance abuse disorders. “It could spare vulnerable individuals the risks associated with unnecessary opioid use.”

Lori Carbonaro, whose son Nick died from a heroin overdose in 2014, watched this development with cautious optimism. “Understanding the long-term effects of Journavx is crucial,” she said. “While I’m skeptical, I do have hope that it can make a positive impact.”

Cost Considerations

The financial aspect presents a significant hurdle for many patients. At $30 per day for a two-pill dose, Journavx is nearly double the average out-of-pocket cost for acetaminophen/hydrocodone combinations. However, given its intended short-term use, experts argue that patients should only need to take it for a few days.

Jeffrey Reynolds, president and CEO of the Family & Children’s Association in Mineola, believes that Journavx could benefit patients who have been undertreated for pain due to providers’ reluctance to prescribe opioids. “Opioid usage has shifted from OxyContin and hydrocodone to more potent drugs like fentanyl. Journavx could address this gap effectively,” he commented.

Dr. William Caldwell, medical director at the Stony Brook Center for Pain Management, highlighted the medication’s potential to mitigate opioid use disorders. “Managing acute pain without opioids can prevent patients from developing opioid use disorder, which many opioids pose a significant risk for,” he stated.

Conclusion: A Promising Step

The approval of Journavx marks a significant step in pain management without the risks associated with opioids. While it is not a panacea and comes with its own set of limitations, including cost and questions about long-term effects, it offers a valuable new tool in the ongoing battle against the opioid crisis.

Patients and their advocates remain cautiously optimistic, hoping that Journavx can contribute to a safer, more effective pain management landscape. As medical professionals and policymakers continue to explore ways to enhance access and affordability, this new treatment could play a crucial role in protecting public health.

Robert Brodsky is a breaking news reporter who has worked at Newsday since 2011. He holds degrees from Queens College and American University.