On Thursday, the US Food and Drug Administration (FDA) approved a new type of prescription pain medicine for adults to treat moderate to severe acute pain.
Journavx (suzetrigine), created by biotech business Vertex Pharmaceuticals, is a non-opioid painkiller with no addictive qualities, unlike opioids that are commonly used to treat this type of pain.
This is the FDA’s first approval of a non-opioid pain drug class to treat moderate to severe acute pain in almost two decades.
“Today’s approval is an important public health milestone in acute pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a press statement. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
In two clinical trials on persons aged 18 to 80, Journavx reduced moderate to severe acute pain by 50% within 48 hours from baseline.
The average time to meaningful pain reduction was two to four hours, versus eight hours in the placebo group.
Journavx inhibits the NaV1.8 pain signal in the peripheral nerve system. This channel is not expressed in the brain or anyplace else in the central nervous system, therefore the medicine does not have the addictive features of opioids, according to Vertex.
Journavx was found to be as effective as hydrocodone, an opioid pain medication, at relieving acute pain, with the added benefit of being non-opioid and non-addictive.
Another clinical trial investigated the medicine in individuals with a larger spectrum of surgical and non-surgical acute pain problems and found it to be both safe and effective.
When looking at several acute pain types, more than 80% of patients in this clinical research rated Journavx as good, very good, or outstanding.
The new drug “offers a safer option for managing moderate-to-severe acute pain, reducing reliance on opioids,” Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic, who was not involved in the clinical trials, told ABC News. “It offers rapid relief and can be integrated into postoperative pain protocols or acute pain scenarios where immediate relief is critical.”
“By managing acute pain effectively, [Journavx] may help prevent the transition to chronic pain, reducing the need for long-term pain management strategies,” according to him.
Some individuals may be unable to use Journavx if they are taking other medications that suppress a specific liver enzyme. Grapefruit should also be avoided when using Journavx.
