Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine) on January 30, 2025, a first-in-class treatment for adults with moderate-to-severe acute pain. This oral, non-opioid medication is a highly selective NaV1.8 pain signal inhibitor.
JOURNAVX™ offers an effective, well-tolerated option for various types of moderate-to-severe acute pain, without evidence of addictive potential. The FDA granted Priority Review to suzetrigine, setting a PDUFA target action date of January 30, 2025.
Addressing Unmet Needs in Pain Management
Acute pain management has long relied on opioids, which carry significant risks of addiction and adverse effects. Suzetrigine represents a novel approach by selectively inhibiting the NaV1.8 sodium channel, a key mediator of pain signals. This targeted mechanism aims to provide effective analgesia while minimizing the risks associated with traditional opioid treatments.
Clinical Development and Trial Data
Suzetrigine's approval was supported by data from Phase 3 clinical trials demonstrating its efficacy and safety in treating moderate-to-severe acute pain. Vertex continues to enroll and dose patients with diabetic peripheral neuropathy (DPN) in a Phase 3 pivotal trial of suzetrigine. Following the December 2024 release of Phase 2 results with suzetrigine in painful lumbosacral radiculopathy (LSR), Vertex plans to advance suzetrigine into pivotal development for painful LSR, pending discussions with regulators on the study design and regulatory package.
Regulatory and Market Access
The Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, effective January 1, 2025, mandates that Medicare provide separate add-on payments for FDA-approved non-opioid pain treatments in hospital outpatient or surgical center settings. Vertex anticipates that suzetrigine will be included on the list of treatments qualifying for these add-on payments, following potential FDA approval. Furthermore, seven states have recently enacted legislation specifying that opioids are not preferred over non-opioid therapies for retail pain treatment.
Ongoing Pipeline Expansion
Vertex is also developing VX-522, a CFTR mRNA therapeutic in collaboration with Moderna, for the more than 5,000 people with CF who cannot benefit from CFTR modulators. Data from the multiple ascending dose (MAD) portion of the Phase 1/2 study of VX-522 is expected in the first half of 2025.
Strategic Collaborations
Vertex has entered into an exclusive collaboration and license agreement with Zai Lab for the development and commercialization of povetacicept in mainland China, Hong Kong, Macau, Taiwan, and Singapore. Zai Lab will help advance clinical trials and make regulatory submissions in the licensed territory, and they will also be responsible for all commercialization activities in the licensed territory upon potential approval of povetacicept.
