FDA approves first non-opioid pain medicine in more than 20 years – Ars Technica
The drug, Journavx (suzetrigine), inhibits an ion channel in peripheral nerves.
The Food and Drug Administration announced the approval of a new non-opioid pain medication this week, marking the first time in over two decades that the agency has approved a non-opioid pain drug with a novel mechanism of action.The drug, Journavx (suzetrigine), is an oral pill that treats acute pain, such as from surgery or injuries. Unlike opioids, which work by latching onto receptor proteins on nerves in the central nervous system, suzetrigine works only in peripheral nerves—that is, those outside the brain and spinal cord. Specifically, the drug inhibits a voltage-gated sodium ion channel called 1.8 (NaV1.8) that is known to relay pain signals, but only in peripheral nerves.Because it works outside the brain by a different mechanism than opioids, the new medication offers a safe alternative to opioids, which can be highly addictive.For its approval, the FDA relied on data from two randomized, double-blind, placebo- and active-controlled trials on patients who were recovering from surgeries—either tummy tucks (abdominoplasty) or bunion removal. Patients had access to ibuprofen as a “rescue” pain medication. Both trials showed that suzetrigine led to clinically meaningful reductions in pain and was safe.The approval “is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “A new non-opioid 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.”The company behind the drug, Vertex, said a 50 mg pill that works for 12 hours will have a wholesale cost of $15.50, making the daily cost $31 and the weekly cost $217. The cost is higher than cheap, generic opioids. But, a report from The Institute for Clinical and Economic Review in December estimated that suzetrigine would be “slightly cost-saving” relative to opioids if the price was set at $420 per week, given the drug’s ability to avert opioid addiction cases.In a statement, Reshma Kewalramani, the CEO and President of Vertex, trumpeted the approval as a “historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year … [W]e have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”Ars Technica has been separating the signal from
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