The FDA has approved the first non-opioid pain medication in 20 years
The FDA has approved the use of the first innovative non-opioid analgesic in 20 years, which blocks pain signals without affecting the central nervous system. The drug developed by Vertex has shown high efficacy in clinical trials and may become an alternative to opioids, which tens of thousands of people become addicted to every year.
The US Food and Drug Administration (FDA) has approved a non-opioid drug for the treatment of moderate to severe acute pain, Journavx (suzetrigine). This was reported by the press service of the pharmaceutical company Vertex Pharmaceuticals.
Mechanism of action
Its development was the first analgesic of a new class registered in the last more than 20 years. The drug acts by blocking the NaV1.8 sodium channel in the peripheral nervous system — it is expressed exclusively in pain neurons (nociceptors) and is responsible for transmitting pain signals. At the same time, the drug affects only the peripheral nerves and does not penetrate the brain, so it is not addictive, unlike opioid painkillers.
Clinical trials
The effectiveness of the drug was confirmed by the results of phase III of two studies involving about 1,000 people who underwent surgery. They were given either a placebo, the opioid Vicodin (hydrocodone + acetaminophen), or Journavx.
After abdominoplasty (surgery for aesthetic correction of the abdomen), 61% of patients taking Vertex noted a reduction in pain by at least 30%. In the placebo group, 48% of participants reported similar pain relief.
After bunionectomy (correction of the protruding bone at the big toe), a significant reduction in pain was observed in 83% of the subjects who received Journavx. A comparable analgesic effect was recorded in 68% of patients in the placebo group.
The opioid drug showed a more pronounced reduction in pain, but it was more likely to cause side effects. In the first trial, nausea and vomiting bothered 33% of participants in the Vicodin group and 20% in the Journavx group. In the second study, 16 and 9% of patients, respectively, complained of the same adverse reactions.
Journavx had mild to moderate side effects in the form of itching, rash, and muscle cramps. In some cases, the drug caused an increase in creatine phosphokinase levels in the blood, usually indicating damage or destruction of muscle cells.
The analgesic effect after taking Journavx occurred after 2-4 hours. Meanwhile, in the placebo group, pain disappeared after an average of eight hours.
Development history
It took more than two decades to create the drug, the New York Times newspaper writes. The research began after the discovery of two genetic mutations in Asia, which helped scientists better understand the mechanism of transmission of pain impulses in the body. Subsequently, they were able to identify the key role of the NaV1.7 channel in these processes.
Social significance
About 80 million people receive prescriptions for analgesics in the United States each year, with about half of them prescribed opioid medications. As a result, 85,000 patients develop drug dependence. The emergence of a non-opioid alternative will reduce the risks associated with the use of narcotic painkillers.
Cost and prospects
Taken twice a day, Journavx will cost $15.50 per 50 mg tablet. Vertex is also studying its effect on peripheral neuropathic pain, a pathological condition in which damaged neurons spontaneously generate pain impulses without the presence of a real physical stimulus.
In addition, the manufacturer plans to start research on the drug among patients with lumbosacral radiculopathy.
According to the forecast of the analytical company Leerink Partners, cited by the Fierce Pharma portal, the annual sales volume of Journavx will amount to $ 866 million in 2026.
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