On Thursday, the US Food and Drug Administration (FDA) approved Journavx (suzetrigine), a novel non-opioid pain medication produced by Vertex Pharmaceuticals Inc. The approval offers a non-addictive alternative to opioids for treating moderate to severe acute pain in adults.
Journavx will be available as a 50-milligram prescription tablet taken every 12 hours, with an initial dose of 100 milligrams followed by 50 milligrams every 12 hours. The medication works by blocking pain signals in peripheral nerves before they reach the brain, differing from opioids that block the brain's perception of pain.
Vertex Pharmaceuticals conducted two large clinical trials, each with approximately 1,000 patients who had pain from either surgery or tummy tucks, demonstrating Journavx's effectiveness in reducing post-surgery pain compared with a placebo. Patients who received Journavx reported about a 50% reduction in their pain after 48 hours, with an average pain level reduction of about 3.5 points, and they experienced much greater pain reduction than those receiving the placebo.
In trials involving 874 participants who experienced acute pain following surgery, Journavx demonstrated better pain relief than a placebo, although its effect was noted to be modest. Additionally, Journavx did not outperform a common opioid-acetaminophen combination pill, and the research was not designed to directly compare suzetrigine with Vicodin, making it difficult to know if one worked better than the other.
Clinical trial participants experienced some side effects, including itching, rash, muscle spasms, nausea, constipation, headaches, and increased levels of creatine phosphokinase. Despite these side effects, Journavx was generally safe and well tolerated in the clinical trials.
Journavx will cost $15.50 per pill, making it much more expensive than some opioid drugs, which often retail as generics for $1 or less. While Vertex Pharmaceuticals asserts that the cost of Journavx is in line with other brand-name pain medications, some experts raised concerns about its affordability for patients who may need long-term treatment.
Evidence suggests that Journavx doesn't pose a risk of addiction as opioid medications do, making it a potentially safer alternative for pain management. "A new therapeutic class of non-opioid analgesics for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option," said Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, according to Fox Business.
"We have the opportunity to change the paradigm of acute pain management and establish a new standard of care," stated Reshma Kewalramani, CEO of Vertex Pharmaceuticals, according to USA Today. Vertex Pharmaceuticals is working on expanding the use of Journavx for chronic pain through ongoing clinical trials, and the company disagrees with critics, stating it tested the medication in different types of chronic pain and it seemed to work for long-term pain as well.
Journavx faces hurdles in winning over physicians, hospitals, and insurance companies, which could limit the ability of some patients to obtain it. Moreover, Vertex Pharmaceuticals encountered a setback in December when a mid-stage trial showed Journavx failed to work better than a placebo in lower back pain, which could present a challenge for the company as new drugs typically must outperform existing treatments to gain traction.
Wall Street analysts expect that Journavx, whose active ingredient is suzetrigine, could bring in about $100 million in sales this year, despite the hurdles it faces in adoption. Following the approval of Journavx, Vertex Pharmaceuticals' shares gained over 8% in after-hours trading, reflecting investor optimism about the drug's potential.
In Florida, where opioid addiction has become a major public health issue, the approval of Journavx could provide a safer alternative for pain management. Opioids, though effective, can cause serious side effects and carry a high potential for misuse, including addiction and overdose. The Centers for Disease Control and Prevention (CDC) reported that every year tens of thousands of Americans die from opioid use, with 82,000 opioid-involved overdose deaths reported in 2022.
"It's an important step forward because it provides proof of concept that a sodium channel blocker can reduce pain in humans," said Dr. Stephen Waxman, who directs the Center for Neuroscience and Regeneration Research at Yale School of Medicine, according to CNN. Journavx represents a shift in how we think about pain treatment.
The FDA's approval of Journavx offers patients and healthcare providers a new non-opioid option for managing acute pain, potentially mitigating certain risks associated with opioid use. As Vertex Pharmaceuticals moves forward, the impact of Journavx on pain management and the opioid crisis will become clearer with real-world use and further clinical studies.
This article was written in collaboration with generative AI company Alchemiq