Journavx intercepts pain signals before they reach the brain
of ConsumerAffairsThe U.S. Food and Drug Administration has approved Journavx (suzetrigine) 50 milligram oral tablets, marking the introduction of a first-in-class non-opioid analgesic designed to treat moderate to severe acute pain in adults.
According to the agency, this approval represents a pivotal moment in the ongoing effort to provide effective pain relief while mitigating the risks associated with opioid use.
While opioids are highly effective as pain relievers they are also highly addictive. Journavx operates by targeting sodium channels in the peripheral nervous system, effectively intercepting pain signals before they reach the brain. This mechanism distinguishes it from traditional opioid-based treatments, offering a safer alternative for those suffering from acute pain, which typically arises from tissue injuries such as trauma or surgery.
The FDA's endorsement of Journavx aligns with its Overdose Prevention Framework, which emphasizes the development of non-opioid pain treatments. The agency has actively supported this initiative through draft guidance and cooperative grants aimed at fostering clinical practice guidelines for managing acute pain conditions.
Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, said the approval offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option."
Statistically significant reduction in pain
The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials involving patients undergoing abdominoplasty and bunionectomy. The FDA said these trials demonstrated a statistically significant reduction in pain for those treated with Journavx compared to placebo, underscoring its potential as a reliable pain management solution.
The new drug is not without potential side effects. Safety data from these trials, which included 874 participants, revealed common adverse reactions such as itching, muscle spasms, increased blood levels of creatine phosphokinase, and rash.
The FDA's approval process for Journavx was expedited, benefiting from Breakthrough Therapy, Fast Track, and Priority Review designations, reflecting the agency's interest in advancing safe and effective alternatives to opioids.
Photo Credit: Consumer Affairs News Department Images
Posted: 2025-01-31 13:54:01
