Vertex Pharmaceuticals’ non-opioid pain medication gets FDA approval

A non-opioid pain medication made by Vertex Pharmaceuticals has received approval for adults from the Food and Drug Administration (FDA).

The company’s “first-in-class” suzetrigine pain pill received the green light for treating moderate to severe acute pain in adults on Thursday, the federal agency said.  

The medication reduces pain “by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain,” according to the FDA.

It will use Journavx as its brand name. 

Vertex CEO Reshma Kewalramani touted Journavx as the “first new class of pain medicine approved in more than 20 years,” adding that the company has the “opportunity to change the paradigm of acute pain management and establish a new standard of care.” 

The medication resulted in a “statistically significant” reduction in pain versus a placebo within two days for patients in a pair of trials who had received abdominoplasties and bunionectomies, according to Vertex. The trials were randomized, double-blind, placebo-controlled and active-controlled. 

“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,” FDA Center for Drug Evaluation and Research Acting Director Dr. Jacqueline Corrigan-Curay said. “This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.” 

Vertex said that almost 10% of patients initially given opioids to quell acute pain end up using opioids, which can be addictive, for a prolonged period of time. 

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Journavx’s wholesale per-tablet acquisition cost will be $15.50, according to the company. 

The FDA said that suzetrigine was “contraindicated” for people using “strong CYP3A inhibitors.” It is also advised that patients taking Vertex’s non-opioid medication not eat or drink anything containing grapefruit.

After the announcement of Journavx’s receipt of FDA approval, Vertex saw gains in its stock price, with its shares posting more than a 5% jump on Friday. Its market capitalization, meanwhile, hovered around $119.81 billion in the afternoon.

The company said it was also looking into peripheral neuropathic pain applications for the medication.  

Vertex has been in business since the late 1980s. Six of the company’s other drugs currently have FDA approval, according to its website.