FDA approves new type of non-opioid pain medication, 1st of its kind in more than 20 years
The U.S. Food and Drug Administration (FDA) on Thursday approved a new type of prescription pain medication for adults to treat moderate to severe acute pain.
The drug, called Journavx (suzetrigine) and manufactured by biotech company Vertex Pharmaceuticals, is a non-opioid painkiller, which doesn’t have addictive properties, unlike opioids often used for this type of pain.
This is the first class of non-opioid pain medication approved to treat moderate to severe acute pain approved by the FDA in more than 20 years.
“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 release. “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, tested on adults between ages 18 and 80, Journavx was found to reduce moderate to severe acute pain for adults from baseline by about 50% in 48 hours.
The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group.
Journavx works by inhibiting the NaV1.8 pain signal in the peripheral nervous system. This channel is not expressed in the brain or anywhere else in the central nervous system, therefore the drug does not have addictive properties like opioids, according to Vertex.
Journavx was found to be as similarly effective as hydrocodone, an opioid pain medication, for reducing acute pain, with the added benefit of being a non-opioid and non-addictive drug.
In another clinical trial, the drug was tested in patients with a broader range of surgical and non-surgical acute pain conditions and was found to be safe and effective.
More than 80% of patients in this clinical trial rated Journavx as a good, very good or excellent pain medication when investigating multiple acute pain types.
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," he added.
The drug cannot be used with certain other drugs that strongly inhibits a certain enzyme in the liver, so some people may not be able to take Journavx, depending on what other medications they are taking. Grapefruit should also be avoided while taking Journavx.
