FDA Approves New Nonopioid Painkiller, Offering Hope for Acute Pain Management
Vertex Pharmaceuticals’ Journavx shows promise in reducing post-surgery pain without the risks of opioids.
The Food and Drug Administration (FDA) has approved a new nonopioid painkiller, Journavx, developed by Vertex Pharmaceuticals, which aims to provide an alternative to opioids for managing moderate to severe acute pain.
The drug, also known by its scientific name suzetrigine, was cleared by the FDA on Thursday for use in adults experiencing short-term pain, particularly following surgical procedures. Experts are hopeful that the approval of suzetrigine, which is considered non-addictive, will help reduce the reliance on opioids for pain management, a critical step in the fight against the opioid epidemic.
Dr. Jacqueline Corrigan-Curay, Acting Director of the FDA's Center for Drug Evaluation and Research, called the approval an “important public health milestone” in the effort to address acute pain while avoiding the pitfalls of opioid addiction.
Clinical specialists like Michael Schatman, a pain management expert at NYU Grossman School of Medicine, expressed optimism, noting the potential of suzetrigine as an opioid-sparing solution for acute pain. “We need more tools in our armory for pain,” Schatman said, emphasizing the drug's promise in reducing opioid prescriptions.
Although the prescription of opioids has declined over recent years, many patients still leave hospitals with prescriptions for these potent painkillers. This is largely due to opioids' effectiveness in pain management, despite their known addictive properties. Experts warn that any exposure to opioids carries the risk of dependence.
Dr. Richard Rosenquist, Chairman of Pain Management at the Cleveland Clinic, highlighted the dangers of opioids in pain treatment, stressing that dependence can arise from any exposure. "We are hopeful that suzetrigine may offer a safer alternative,” he said.
A New Approach to Pain Relief
Unlike opioids, which work by stimulating brain receptors to block pain signals and induce euphoria, suzetrigine takes a different approach. The drug works as a sodium channel blocker, preventing pain signals from reaching the brain in the first place. It targets a specific sodium channel, NaV1.8, which is involved in transmitting pain messages from nerve endings. This is similar to how local anesthetics like lidocaine work but more precise, as suzetrigine only targets the pain-specific channels, sparing other vital systems like the heart and brain.
"This is the first time we’ve seen a drug that specifically targets this sodium channel," Rosenquist explained. He further emphasized that suzetrigine does not produce feelings of euphoria or activate opioid receptors, which significantly reduces the risk of addiction.
Clinical Trial Results and Effectiveness
Suzetrigine was tested in phase 3 clinical trials, particularly looking at its effectiveness after surgeries like tummy tucks and bunion removal. Patients who received suzetrigine experienced a 50% reduction in pain after 48 hours, which was comparable to the reduction seen in patients taking hydrocodone and acetaminophen. Patients who received the non-opioid drug also reported fewer side effects, with common complaints being headaches, constipation, and nausea.
Dr. David Rind, Chief Medical Officer at the Institute for Clinical and Economic Review, noted that the results suggest suzetrigine can be effective for short-term use, though he cautioned that more research is needed to understand its full potential.
Another study revealed that 82% of surgical patients and 91% of non-surgical patients rated suzetrigine’s effectiveness as good to excellent. However, about 37% of participants experienced mild side effects.
Potential in Opioid Alternatives
Suzetrigine’s role in pain management may be particularly beneficial for patients who cannot tolerate traditional pain relievers like NSAIDs or acetaminophen, such as those with liver or kidney disease. Dr. Todd Bertoch, Chief Medical Officer for Pain Research at CenExel JBR Clinical Research, explained that the drug could be a valuable tool in patients’ pain management regimens, especially for those who need to avoid opioids.
The drug is also seen as part of a “step-up” approach to pain management. “If Tylenol or NSAIDs aren’t sufficient, suzetrigine could be the next step before considering opioids,” Bertoch said.
Long-Term Safety and Future Concerns
While experts are optimistic about suzetrigine’s safety and efficacy in the short term, questions remain regarding its long-term use. A report by the Institute for Clinical and Economic Review (ICER) noted that the drug’s data is “promising but inconclusive,” urging more research into its long-term effects and potential risks.
Dr. Schatman raised concerns that suzetrigine, though effective for acute pain, may not be suitable for chronic pain, as it targets the peripheral nervous system, while chronic pain often stems from the central nervous system. Nevertheless, experts like Rosenquist see suzetrigine as a vital addition to the pain management landscape, particularly for post-surgery recovery and reducing opioid exposure.
The drug's future success may hinge on its affordability and availability. Experts hope that if priced competitively, suzetrigine could be an accessible alternative to opioids, offering safer pain relief for patients without the risk of addiction.