FDA approves nonopioid Journavx for moderate to severe acute pain
Key takeaways:
- Journavx became the first drug in a new class of pain management medications to be FDA approved.
- The treatment showed statistically significant superiority to placebo in trials.
The FDA has approved Journavx 50 mg oral tablets for the treatment of moderate to severe acute pain in adults, according to a press release.
The nonopioid analgesic suzetrigine (Journavx, Vertex Pharmaceuticals) becomes the first drug to be approved in a new class of pain management medications known as sodium channel blockers. The agent reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system.
The approval “is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in the release.
“A new nonopioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” she added.
Suzetrigine’s efficacy was assessed in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following bunionectomy and the other abdominoplasty.
Both studies resulted in suzetrigine showing a significantly greater reduction in pain vs. placebo.
The FDA noted that the safety profile of suzetrigine was based on data from the pooled, double-blind trials composed of 874 participants with moderate to severe acute pain after abdominoplasty and bunionectomy.
Meanwhile, supportive safety data were retrieved from a one single-arm, open-label study comprising 256 participants with moderate to severe acute pain in a variety of acute pain conditions.
The most common adverse effects in participants who received suzetrigine included muscle spasms, itching, rash and an increased blood level of creatine phosphokinase.
The FDA added that patients taking suzetrigine should avoid food or drink containing grapefruit, while the medication “is contraindicated for concomitant use with strong [cytochrome P450 3A4] inhibitors.”
The approval “and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” Corrigan-Curay said.
Perspective
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In 2022, nearly 108,000 people tragically lost their lives to drug overdoses, with opioids accounting for approximately 82,000 of those deaths — roughly 76% of the total. The opioid crisis has escalated to a staggering level, with overdose deaths in 2022 being 10 times higher than those recorded in 1999. Despite this grim reality, the rate of opioid overdose deaths remained relatively stable from 2021 to 2022, suggesting a complex plateau rather than a continued exponential rise.
In the face of this ongoing epidemic, suzetrigine has emerged as a promising breakthrough. The newly FDA-approved drug offers a potential alternative to traditional opioids. Suzetrigine holds significant promise, with clinical trials demonstrating its ability to target a specific pain-signaling protein in nerve cells, thereby reducing pain without the risk of physical dependence or addiction that is so prevalent with opioids. This innovation represents a crucial step toward safer pain management solutions.
Two late-stage clinical trials have already demonstrated suzetrigine’s effectiveness in managing acute postsurgical pain, offering an important nonopioid option for patients. However, challenges remain: in some studies, suzetrigine failed to surpass opioids in efficacy, underscoring the ongoing need for more research and a better understanding of its clinical variability. Furthermore, the long-term safety and efficacy of the drug remain largely uncharted because real-world data on its sustained use are still scarce.
Another critical consideration is the cost of suzetrigine, which may limit its accessibility for many patients, particularly those without comprehensive insurance coverage. In a health care landscape already burdened by rising drug prices, ensuring equitable access to such innovations will be key to their success in combating the opioid crisis.
As the CDC has emphasized, tackling the opioid epidemic requires a multifaceted approach, grounded in collaboration and innovation. We must work together — across industries, communities and governmental agencies — to not only address the urgent need for opioid overdose prevention but also to foster the development of nonopioid alternatives. By advancing new treatments and building a more coordinated response, we can make meaningful strides in addressing this public health challenge.
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