The holy grail in addiction treatment is the development of non-addictive painkillers. The issue is so urgent, it’s at the top of the wishlist for breakthrough research at CASPR, the Center for Addiction Science, Policy and Research. If doctors are able to treat surgical pain and chronic pain with a non-addictive drug, millions of people will be spared the scourge of opioid addiction.

It is with great fanfare, then, that the U.S. Food and Drug Administration (FDA) just gave approval to Journavx, the first new class of painkiller in 20 years. Manufactured by Vertex Pharmaceuticals of Boston, Massachausetts, Journavx (suzetrigine), is “an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor.” A news release from Vertex goes into greater detail about how the medication works:

NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). Because JOURNAVX blocks pain signals only found in the periphery, not in the brain, JOURNAVX provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.

The drug has been approved by the FDA for twice daily treatment of adults with moderate to severe acute pain. The wholesale price of the drug is $15.50 per 50mg pill, or about $30/day. Journavx has not been approved for children. Vertex says that Journavx is “an effective and well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.” 

Their news release announcing the new drug is full of platitudes by people associated with Vertex:

“[W]e have the opportunity to change the paradigm of acute pain management and establish a new standard of care.” — Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex

“I believe JOURNAVX could redefine the management of pain…” — Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine in San Diego and Vertex Acute Pain Steering Committee Member

Associated Press health reporter, Matthew Perrone, was a little more down to earth, writing “the medication’s modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.” Journavx may not be the end of the opioid crisis, but it is the beginning of a new way of treating pain which shows great promise. The drug works by blocking proteins that trigger pain signals sent to the brain. 

The research is based on a rare hereditary condition that causes insensitivity to pain. Perrone writes:

Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex’s drug provided more relief than a dummy pill but didn’t outperform a common opioid-acetaminophen combination pill.

The New York Times reports that, while suzetrigine might not be able to replace opioid painkillers across the board, it can be very useful in treating pain that results from nerve damage:

[T]here is also another group that needs pain relief but has few good options — those who have damaged nerves that cause constant pain, called peripheral neuropathic pain. That group includes people with diabetes, which can make the hands or feet hurt or go numb, among other symptoms.

Vertex is now in a phase 3 trial of suzetrigine against this diabetic neuropathic pain. The company hopes to expand trials against chronic pain as well, a much larger potential market for non-opioid painkillers.

Written by Steve O’Keefe. First published February 10, 2025.

Sources:

“Will the new non-addictive painkiller approved by the FDA take the place of opioid drugs?,” Northeastern Global News, January 31, 2025.

“Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain,” Business Wire, January 30, 2025.

“FDA approves painkiller designed to eliminate the risk of addiction associated with opioids,” Associated Press, January 31, 2025.

“F.D.A. Approves Drug to Treat Pain Without Opioid Effects,” The New York Times, January 30, 2025.

Image of JOURNAVX logo (Source: Business Wire).