Written and Reviewed by Team Pharmacally
The US Food and Drug Administration (FDA) have sanctioned Vertex Pharmaceuticals JOURNAVXTM (suzetrigine), a first in class medicine for adult patients with moderate to severe acute pain. The drug is used by selectively inhibiting sodium channels, introducing a novel mechanism of action distinct from traditional pain medications such as opioids or non steroidal anti-inflammatory drugs.
A Paradigm Shift in Pain Management
Suzetrigine represents a breakthrough in the treatment of acute pain, a disorder that touches millions of people every year as a result of injuries, surgeries, and other procedures. In contrast to opioids, which carry with them the risk of dependency and tolerance, or NSAIDs, which carry with them gastrointestinal and cardiovascular side effects, suzetrigine targets sodium channels involved in the propagation of pain messages along nerves. This action not only minimizes the risk of systemic side effects but also gives patients a quicker-acting and more targeted pain relief.
The JOURNAVX™ approval is the result of decades of innovation and commitment to addressing the unmet needs in pain management,” said Dr. Andrea Phillips, Vertex’s Chief Medical Officer. “This first-in-class therapy represents a significant milestone in making effective, non-opioid treatment available to patients with acute pain.”
Clinical Trial Success
The FDA approval is based on data from two Phase 3 pivotal clinical trials, where it was observed that JOURNAVX™ significantly decreased the intensity of pain hours after dosing when compared with placebo. Patients who received suzetrigine in both studies had a 60% greater reduction in intensity of pain at 24 hours post-dosing, and the effects were maintained up to 72 hours in the majority of cases.
The trials also revealed the safety profile of suzetrigine. The most frequent side effects were mild and consisted of nausea, dizziness, and discomfort at the injection site. In contrast to conventional therapies, no serious risks of respiratory depression, gastrointestinal bleeding, or addiction were noted.
Mechanism of Action-Selectivity is the key
Journavx is not the first sodium channel-targeting drug to be used for pain relief. For over one hundred years, drugs such as lidocaine and procaine (Novocain) have been employed to cause reliable anesthetics. To avoid wide-reaching side effects, these earlier drugs have to be administered locally, either by injection or topical skin creams and gels, because sodium channels exist in nine subtypes, and they inhibit all nine indiscriminately.
JOURNAVX (suzetrigine) is the first-in-class non-opioid, oral, highly selective inhibitor of pain signal that selectively inhibits NaV1.8 compared to other NaV channels. Peripheral pain-sensing neurons, or nociceptors, specifically express the voltage-gated sodium channel NaV1.8 to transmit pain signals, or action potentials. JOURNAVX effectively alleviates pain without the disadvantages of available therapies, including the potential for addiction of opioids, because it blocks pain signals only in the peripheral nervous system and not the brain.
Addressing the Opioid Crisis
The approval of JOURNAVX™ comes at a critical time as the healthcare industry continues to grapple with the opioid crisis. According to the CDC, opioid-related overdoses have claimed more than 500,000 lives in the United States over the last two decades. Non-opioid alternatives like suzetrigine could help reduce reliance on addictive medications while still providing effective pain relief.
Suzetrigine provides an exciting opioid alternative for patients with acute pain,” added Dr. Michael Sanderson, a pain management specialist and principal investigator in the clinical trials. “This new treatment has the potential to revolutionize how we treat pain, minimizing the toll of complications from opioids.
Vertex’s Commitment to Innovation
Vertex Pharmaceuticals is also recognized for its pioneering effort in creating treatments for cystic fibrosis and other genetic disorders. With JOURNAVX™, the organization continues to pioneer its way in the field of pain relief. Vertex anticipates making the treatment available in the United States in the coming months and is actively pursuing European and other regulatory approvals.
Today’s approval is a significant public health achievement in the treatment of acute pain,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research.
Looking Ahead
As JOURNAVX™ becomes available; the potential effect on patients and healthcare professionals alike is staggering. In offering a non-opioid, targeted solution to acute pain relief, suzetrigine has the potential to redefine the standard of care and bring hope to millions of suffering patients.
References:
1. US drug agency approves potent painkiller — the first non-opioid in decades, nature, 31 January 2025
2. Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults with Moderate-to-Severe Acute Pain, Vertex Press Release, 30 Jan 2025
3. FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain, First Drug Approved in New Class of Non-Opioid Pain Medicines; Agency Continues to Take Steps to Support New Approaches for Pain Management, Food and Drug Administration, 30 January 2025
4. Osteen, J.D., Immani, S., Tapley, T.L. et al.Pharmacology and Mechanism of Action of Suzetrigine, a Potent and Selective NaV1.8 Pain Signal Inhibitor for the Treatment of Moderate to Severe Pain. Pain Ther(2025). https://doi.org/10.1007/s40122-024-00697-0
5. Eagles DA, Chow CY, King GF. Fifteen years of NaV1.7 channels as an analgesic target: Why has excellent in vitro pharmacology not translated into in vivo analgesic efficacy? Br J Pharm. 2022; 179:3592–611.
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