The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class non-opioid analgesic to treat acute pain in adults.
“Today’s approval is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research said in a 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,” she added.
Corrigan-Curay said the approval underlines the agency’s commitment to “safe” and “effective” alternatives to opioids for pain management.
The new development is groundbreaking because it provides an alternative to opioids. Tens of millions of Americans are prescribed opioids like hydrocodone, oxycodone and fentanyl each year for pain.
Nearly 108,000 people died from drug overdoses in 2022, with approximately 82,000, or 76 percent, of those deaths stemming from opioid usage, according to the Center for Disease Control.
After the FDA’s approval, suzetrigine became the first new painkiller approved in the US in 27 years.
Journavx was evaluated in two randomized controlled trials of acute surgical pain. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo, according to the FDA.
The 50-milligram prescription pill which contains the drug suzetrigine will be taken every 12 hours after a larger starter dose.
