FDA approves first non-opioid pain medicine in more than 20 years

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.”