FDA approves 1st new class of opioid-free painkillers in over 20 years

The Food and Drug Administration (FDA) has greenlit a new type of pain medication for the first time in more than 20 years. What’s more, the new painkiller doesn’t include opioids like many painkillers currently on the market do.

The FDA announced Thursday (Jan. 30) that it had approved the new class of prescription painkiller called suzetrigine, sold under the brand name Journavx.

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” Dr. Reshma Kewalramani, CEO and president of Vertex Pharmaceuticals, the drug’s manufacturer, said in a statement.

Journavx can treat moderate to severe acute pain, meaning short-term pains caused by things like physical trauma or surgery, according to the statement. Doctors often treat this type of pain with painkillers, or analgesics, that can contain opioids.

Opioids are a class of drugs that work by activating specific receptors in the brain and body and by doing so block pain signals. While they may offer effective pain management, they can also induce a “high” or a sense of euphoria. These effects can reinforce the act of taking the drug and thus make them very addictive, according to the National Institute on Drug Abuse (NIDA).

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Opioid addiction, or opioid use disorder, is a public health crisis in the U.S. In 2022, 76% of drug overdose deaths involved opioids — found in both legally prescribed medicines and illegal drugs, such as heroin — which amounted to 82,000 people, according to the Centers for Disease Control and Prevention (CDC). The vast majority of opioid drug overdose deaths involve illegally manufactured fentanyl, according to NIDA.

The newly approved drug suzetrigine doesn’t produce a high like opioids can. Instead, Journavx blocks pain signals in peripheral pain-sensing neurons, or nociceptors. These neurons are in the peripheral nervous system, meaning they’re not the brain, so they can provide pain relief without carrying the addictive potential of opioids, according to Vertex Pharmaceuticals.

Researchers tested Journavx in trials involving 874 participants who experienced acute pain following surgery, according to the FDA’s statement. The researchers conducted two randomized, double-blind trials, which means the drug was randomly assigned to some patients while others got a placebo, and neither the doctors nor the patients knew who had the real medication. The participants also had access to ibuprofen — a non-opioid — if needed. (Ibuprofen works by messing with enzymes involved in producing pain signals and inflammation.)

The trials found that patients taking Journavx had much greater pain reduction than those with the placebo, according to the FDA statement. Journavx has been approved to treat adults only, and Vertex Pharmaceuticals notes that it’s currently unknown whether the drug is safe and effective for children.

Common Journavx side effects include itching, a rash, muscle spasms and increased levels of creatine phosphokinase, an enzyme often associated with stress or injury that some medications can drive up in concentration.

Journavx may also temporarily hinder female fertility, reducing the chances of becoming pregnant during treatment, according to Vertex Pharmaceuticals. Patients who have concerns about this should speak with their doctor before taking the drug, the company advises.

“Today’s approval is an important public health milestone in acute pain management,” Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in the 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.”