New Painkiller Type Approved by FDA After Decade-Long Drought of Opioid Alternatives
In the realm of addressing acute pain, U.S. doctors often rely on opioids - potent painkillers known for their dangerous side effects, including an alarming risk of addiction and overdose. Now, the U.S. Food and Drug Administration (FDA) has given the green light to a revolutionary alternative: a new non-opioid pain medication, suzetrigine, marketed as Journavx.
Suzetrigine, representing the first new class of pain medicine approved by the FDA in two decades, has secured approval to treat acute pain in adults. It's also the first medication of its kind to receive FDA approval. This significant breakthrough in pain management was highlighted in a statement issued by the FDA recently.
Jessica Oswald, a member of the Vertex Acute Pain Steering Committee, expressed her elation in a Vertex statement, saying, "This is a fantastic day for patients and physicians who now have a non-opioid treatment option that provides effective acute pain relief with a favorable safety profile, sans addictive potential." Vertex Pharmaceuticals, a Boston-based biotech company, developed this game-changing drug.
Since 1999, hundreds of thousands of Americans have fallen victim to opioid overdose, despite the escalating crisis. Despite this, doctors in the U.S. distributed an staggering 125 million opioid prescriptions in the year 2023 alone.
Opioids interact with receptors in the brain to block pain signals and release endorphins - the body's natural painkillers. This interaction often leads to addiction. Suzetrigine, however, functions differently, selectively blocking sodium channels on pain-sensing neurons, preventing the pain signal from reaching the brain in the first place. Unlike opioids, it doesn't produce any opioid-like "high."
Richard Rosenquist, of the Neurological Institute at the Cleveland Clinic, told NBC News, "At present, all evidence suggests it has no addiction potential at all. It's just like Tylenol or ibuprofen in terms of addiction potential."
Suzetrigine tested positive in clinical trials, demonstrating a significant reduction in pain from baseline at 48 hours on the Numeric Pain Rating Scale (NPRS) after both abdominoplasty and bunionectomy surgeries. It provided pain relief comparable to that of a combination of hydrocodone and paracetamol (acetaminophen). In the single-arm safety and efficacy study, 83.2% of patients assessed suzetrigine as good, very good, or excellent for managing pain based on the Patient Global Assessment (PGA) scale.
However, given its steep price - $15.50 per 50-milligram pill - it remains to be seen if suzetrigine has the practical potential, in addition to its medical potential, to become a widespread alternative to opioids.
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In the future of pain management, the approval of suzetrigine could potentially decrease the reliance on opioids due to its favorable safety profile and lack of addictive potential. Advancements in science and technology have led to the development of suzetrigine, which operates differently than opioids to block pain signals.
