Suzetrigine: First-in-Class Non-Opiate Pain Therapy is Approved by FDA

Suzetrigine (Journavx; Vertex Pharmaceuticals) received approval from the FDA for the treatment of adults with moderate-to-severe acute pain, according to an announcement from Vertex.1 The therapy is a novel oral, non-opioid, highly selective NaV1.8 pain signal inhibitor.

Suzetrigine is both the first drug in the class of medications known as selective NaV1.8 pain signal inhibitors and the first new drug approved to treat acute pain in over 20 years. The decision came amid the ongoing opioid crisis, just a week after Purdue Pharma and the Sackler family settled opioid-related lawsuits for $7.4 billion.2 Vertex is one of several companies aiming to introduce nonopioid pain treatments as alternatives to traditional opioid medications.

The opioid crisis continues to shape pain management, with overdose deaths still alarmingly high.

Image Credit: syahrir - stock.adobe.com

The opioid crisis continues to shape pain management, with overdose-related deaths still alarmingly high despite a 12% drop in prescription opioid–related deaths from 2021 to 2022.3 Although regulators have cracked down on opioid prescriptions, millions of patients are left without effective alternatives, highlighting a treatment gap for patients in need of pain treatment.

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” Reshma Kewalramani, MD, CEO and president of Vertex said in a statement.1 “With the approval of Journavx, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

The therapy is backed by multiple clinical trials, including a pair of phase 2 and 3 phase 3 studies.2 In the NAVIGATE 1 and NAVIGATE 2 (NCT05661734) trials, which focused on postsurgical pain relief, suzetrigine demonstrated greater efficacy in patients recovering from abdominoplasty, with a pain score reduction of 48.4 points compared with a 29.3-point reduction in bunionectomy patients.

However, not all results have been as promising. A phase 2 trial in patients with lumbosacral radiculopathy showed only a slight numerical advantage over placebo, raising concerns among analysts. Despite this, suzetrigine offers the potential to energize the nonopioid pain market, which includes other companies like Tris Pharma, Latigo Biotherapeutics, and SiteOne Therapeutics—all actively developing alternatives to opioids.

Key findings from the Institute for Clinical and Economic Review analysis of the phase 3 trials include potential lifetime cost savings of $200 per patient when comparing suzetrigine with opioids, assuming a 1-week course priced at $420.4 However, uncertainties remain regarding suzetrigine's long-term safety profile, underscoring the need for continued monitoring post-market release.

References

1. Vertex announces FDA approval of JOURNAVX™ (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain. News release. Vertex Plarmaceuticals. January 30, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class

2. McKenzie H. Vertex awaits FDA verdict on landmark non-opioid pain drug. Biospace. January 30, 2025. Accessed January 30, 2025. https://www.biospace.com/fda/vertex-awaits-fda-verdict-on-landmark-non-opioid-pain-drug

3. Baxter A. A long-awaited alternative to opioids is on the FDA doorstep. Can Vertex seal the deal? PharmaVoice. January 29, 2025. Accessed January 29, 2025. https://www.pharmavoice.com/news/opioid-alternative-fda-vertex-pharma-protega-pharma/738562/

4. Myshko D. ICER: potential new pain medication offers small savings. Managed Healthcare Executive®. December 9, 2024. Accessed January 29, 2025. https://www.managedhealthcareexecutive.com/view/icer-potential-new-pain-medication-offers-small-savings