FDA Approves Vertex’s Journavx: A Breakthrough Non-Opioid Pain Medication
The FDA approved Journavx (suzetrigine) on January 30, 2025, for treating moderate-to-severe acute pain in adults14.
Journavx is the first new class of pain medicine approved in over 20 years, offering a non-opioid alternative for pain management13.
Developed by Vertex Pharmaceuticals, Journavx is a highly selective NaV1.8 pain signal inhibitor that works on the peripheral nervous system without affecting the brain's reward centers19.
Clinical trials demonstrated Journavx's effectiveness in reducing pain after surgery, with a favorable safety profile and no evidence of addictive potential13.
The drug is priced at $15.50 per pill, or about $30 per day, with Vertex establishing patient support programs to help ensure access3.
Journavx's approval is seen as a significant milestone in addressing the opioid crisis, potentially reducing reliance on addictive pain medications46.
The FDA granted Journavx Breakthrough Therapy, Fast Track, and Priority Review designations, underscoring its importance in pain management4.
While effective against placebo, Journavx did not prove superior to a combination of hydrocodone bitartrate and Tylenol in clinical trials23.
Vertex is positioning Journavx as a valuable alternative to opioid-based therapies, emphasizing its safety profile and lack of addictive properties35.
The approval of Journavx is expected to potentially change the paradigm of acute pain management and establish a new standard of care in pain treatment16.
Sources:
1. https://www.drugs.com/newdrugs/fda-approves-journavx-suzetrigine-first-class-adults-moderate-severe-acute-pain-6445.html
2. https://finance.yahoo.com/news/non-opioid-drug-vertex-cuts-063000807.html
3. https://www.biopharmadive.com/news/vertex-pain-non-opioid-drug-fda-approval-journavx/738721/
4. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain
5. https://www.biospace.com/drug-development/vertex-unveils-full-phase-iii-data-for-non-opioid-pain-candidate-touts-safety-profile
6. https://pharmasource.global/content/biotech-news/vertex-pharmaceuticals-secures-fda-approval-for-journavx-a-non-opioid-pain-treatment/