Associate Professor Jacqueline Cleary maintains a pharmacy practice at Saratoga Community Health Center and teaches courses in pain management. She also enlists students in efforts to reduce the effects of opioid addiction in the community. We asked Dr. Cleary about Journavx, the first new class of non-opioid pain medication to receive federal approval in two decades.
What is Journavx, and how does it work to relieve pain?
Journavax is the brand name for a drug called suzetrigine that was approved in late January by the U.S. Food and Drug Administration to treat moderate to severe acute pain in adults. Importantly, this drug is not an opioid. It targets sodium channels in the pathway where pain signals get sent in your nervous system. Essentially this drug stops the pain signal from reaching the brain.
What types of pain is Journavx approved to treat, and who might benefit from it?
Currently this drug is approved for acute pain only. Two studies were completed looking at the use of suzetrigine after surgery. The drug was used effectively in the first 48 hours after bunionectomy and abdominoplasty.
It has also been tested in nonsurgical patients; however, the data is smaller and more work is needed. There are ongoing trials looking at suzetrigine for diabetic peripheral neuropathy and longer-term use.
What are the potential side effects and risks associated with Journavx?
Overall, the drug was well tolerated in the two studies submitted to the FDA. The main side effects were muscle spasms, increased levels of creatine phosphokinase (which may be associated with muscle pain or weakness), and rash. Headache and constipation have also been reported.
I have gotten questions about fertility effects on women with the use of suzetrigine as there is a warning in the package insert of the drug. This warning comes from studies on rats that were given 2.2 times the highest dose of the drug. Those rats experienced an effect on their progesterone receptor leading to infertility; however, this effect was reversed after four weeks without the drug. Also, this effect has not yet been demonstrated in humans. Female patients who are of reproductive age should consider all the facts when deciding whether to take suzetrigine.
Are there any important drug interactions people should be aware of before taking Journavx?
Suzetrigine is primarily metabolized by the 3A4 enzyme in the liver. That enzyme activity can be increased or decreased by drugs or even foods that affect 3A4 as well.
Inhibitors of 3A4 may include antibiotics, antidepressants, antifungals and even grapefruit juice in large amounts. Inducers (increasers) of 3A4 may include antiseizure medications and steroids.
Patients using these medications should consult with their doctors before taking suzetrigine.
As a professional dedicated to addressing the negative effects of other, addictive painkillers like opioids, are you hopeful about Journavx?
I am incredibly hopeful for suzetrigine and others like it to be approved. Pain continues to be the No. 1 reason people seek medical care. We are so limited in non-opioid medications, and the opioids are absolutely not without risk.
This is certainly a breakthrough approval of a compound that can treat pain with a safer side-effect profile while not posing a significant potential for dependence.