The FDA has approved a new non-opioid pain medication, the first in 20 years

The FDA has approved a new non-opioid pain medication, the first in 20 years

On Thursday, the US Food and Drug Administration (FDA) approved a new type of prescription pain medication for adults to treat moderate to severe acute pain.

Journavx (suzetrigine), manufactured by biotech company Vertex Pharmaceuticals, is a non-opioid painkiller with no addictive properties, unlike opioids that are commonly used to treat this type of pain.

This is the FDA’s first approval of a non-opioid pain medication class to treat moderate to severe acute pain in over two decades.

“Today’s approval is an important public health milestone in acute pain management,” stated 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 involving adults aged 18 to 80, Journavx was found to reduce moderate to severe acute pain in adults by approximately 50% from baseline in 48 hours.

The average time to meaningful pain relief was two to four hours, versus eight hours in the placebo group.

Journavx inhibits 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, so the drug does not have the addictive properties 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 tested the drug in patients with a broader range of surgical and non-surgical acute pain conditions and found it to be both safe and effective.

When looking at multiple acute pain types, more than 80% of patients in this clinical trial rated Journavx as good, very good, or excellent.

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.

The drug cannot be combined with certain other drugs that strongly inhibit a specific enzyme in the liver, so some people may be unable to take Journavx, depending on their other medications. Grapefruit should also be avoided when taking Journavx.

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