FDA Approves First-in-Class Non-Opioid Pain Reliever
Journavx (suzetrigine) – a first-in-class, non-opioid analgesicA new non-opioid pain treatment option
On January 30, 2025, the FDA granted priority review for Journavx (suzetrigine) – a first-in-class, non-opioid analgesic for treating moderate to severe acute pain in adults.
How It Works
Journavx targets sodium channels in the peripheral nervous system, interrupting pain signals before they reach the brain — offering a novel mechanism of action with no opioid involvement.
Key Trial Results
- Evaluated in two surgical pain studies (abdominoplasty and bunionectomy).
- Patients using Journavx had significantly better pain relief than those on placebo.
- Common side effects: itching, muscle spasms, rash, and elevated creatine phosphokinase.
Warnings
Users should avoid grapefruit and strong CYP3A inhibitors due to interaction risk.
Why It Matters
This marks the first approval in a new class of non-opioid pain medicines, aligning with the FDA’s push to expand safer alternatives amid the opioid crisis.
Approved by: Vertex Pharmaceuticals
Designations: Breakthrough Therapy, Fast Track, Priority Review
Journavx offers a promising new option for acute pain relief — without the risks of opioids.
Editor’s Note: This is another in our series of potentially game-changing novel pharmaceuticals that FDA approved in 2024 and 2025. This approval report does not in any way recommend or promote this product. For more information contact your oncologist or the manufacturer. Report any adverse effects experienced with this product to FDA’s Medwatch System.
Fresenius Kabi Recalls Ivenix Infusion Pump Software
Urgent Class I Recall Notice A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is...
FDA – Do Not Use Non-piercing Devices to Measure Blood Glucose
FDA Safety Communication On February 21, 2024 the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the use of smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing. Its cautionary...
Medos International Recalls CEREBASE DA Guide Sheath
Urgent Class I Recall Notice Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...