FDA Approves Journavx, a First-of-Its-Kind Non-Opioid Painkiller for Acute Pain—Here’s What to Know
The medication currently shows no addictive properties
A massive stride has been made in the pain medication industry. The U.S. Food and Drug Administration (FDA) announced Thursday its approval of a non-opioid treatment for moderate to severe acute pain in adults called Journavx—the first-in-class in more than 20 years. Keep reading for everything you should know about the new pain management medication.
What is Journavx: the new non-opioid painkiller for acute pain?
Journavx is the brand name for suzetrigine, a 50-milligram prescription non-opioid pain reliever for moderate to severe acute pain in adults. It reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain, the FDA says.
According to Vertex Pharmaceuticals, manufacturer of Journavx, the drug blocks pain signals only found in the periphery, not in the brain, so it provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.
Woman's World Answers
Journavx clinical trial results
The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain. One followed abdominoplasty and the other took place after bunionectomy (a procedure that moves a person’s toes back into the correct position).
Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to the placebo group, study findings revealed.
The safety profile of Journavx was also tested in 874 participants with moderate to severe acute pain following the same surgeries, with additional safety data from one study in 256 participants with moderate to severe acute pain from a variety of conditions.
The most common adverse reactions in study participants who received Journavx were itching and rash, muscle spasms and increased blood level of creatine phosphokinase, the studies found.
The FDA also notes that Journavx should not be taken along with strong CYP3A inhibitors (certain antibiotics, antivirals, antifungals, cardiovascular drugs and proton pump inhibitors), or food or drink containing grapefruit.
Possible limitations of Journavx
In a third study including people struggling with back pain caused by sciatica, suzetrigine reduced pain by about 2 points, the same amount reported by people taking a placebo, suggesting that this drug is likely not significantly effective for chronic pain.
This makes sense as Journavx is approved for the treatment of acute pain in particular, which refers to short-term, often sudden pain that is typically in response to some form of tissue injury, such as trauma or surgery. Chronic pain like sciatica, on the other hand, is pain that persists beyond the usual recovery period or occurs along with a chronic health condition.
However, the company is currently testing Journavx for the treatment of peripheral neuropathic pain (PNP).
Experts respond to approval of Journavx
Speaking with NBC News, Richard Rosenquist, MD, enterprise chairman in the department of pain management in the Neurological Institute at the Cleveland Clinic, cited CDC data showing that anyone who gets exposed to opioids has the potential to have a dependence on them. Dr. Rosenquist was not involved with research on the drug.
“This is the first time we have had something that targets a specific sodium channel,” he said. “Right now all the evidence suggests this has no addiction potential at all. It’s no different than Tylenol or ibuprofen in terms of addiction potential.”
Some of the participants in the phase 3 trial took ibuprofen in addition to suzetrigine if they felt they still needed it after their Journavx doses.
“The results we have now do not tell us a lot about how much of a rescue medication was used,” David Rind, MD, chief medical officer at the Institute for Clinical and Economic Review (ICER) told NBC. “We don’t know if they would have had higher pain reduction if they had just taken an NSAID from the start.”
How much will Journavx cost?
Vertex has established a wholesale acquisition cost for Journavx in the United States of $15.50 per 50mg pill, the company says.
Conversation
All comments are subject to our Community Guidelines. Woman's World does not endorse the opinions and views shared by our readers in our comment sections. Our comments section is a place where readers can engage in healthy, productive, lively, and respectful discussions. Offensive language, hate speech, personal attacks, and/or defamatory statements are not permitted. Advertising or spam is also prohibited.
