The FDA’s sign-off on the medication comes as the agency says it is prioritizing supporting the development of non-opioid pain treatment
FDA Approves non-Opioid painkiller to combat addiction crisis
The U.S. Food and Drug Administration has approved Journavx, a new non-opioid painkiller for short-term pain in adults.
Cover Media – Shareable
For the first time in two decades, the Food and Drug Administration (FDA) has approved a new class of medication that provides an alternative to addictive opioids for patients looking to manage certain kinds of pain.
The drug, suzetrigine, received the FDA’s official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release. The medication will be sold under the brand name Journavx for $15.50 per pill, according to Vertex Pharmaceuticals, the company that developed the new drug.
The FDA’s sign-off on the medication comes as the agency says it is prioritizing supporting the development of non-opioid pain treatment. Suzetrigine is the first non-opioid analgesic – or medication to control pain – of its class to receive federal approval in more than 20 years.
Vertex Pharmaceuticals claimed in a press release that the medication can be used for many types of moderate-to-severe acute pain and has shown no evidence that it is addictive, like opioids.
“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. “This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”
FDA approval of Journavx comes after 2 drug trials
Journavx was evaluated in two random double-blind experiments with a total of 874 participants following surgical procedures in which information was withheld from participants that may have influenced their behavior or perceptions.
One of the drug trials followed abdominoplasty surgeries – known colloquially as a “tummy tuck” – while the other followed bunionectomies, or an operation on toes. Both trials involved randomly administering placebos and the active drug, and all participants were able to use ibuprofen if the pain became too great.
“Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo,” the FDA said in its press release.
How does Journavx work?
Acute pain is something more than 80 million Americans fill prescriptions to treat each year, according to Vertex.
As opposed to chronic pain, which can last well after an injury or illness has been treated, acute pain is more sudden – often caused by surgery or injury – and is easier to treat in the short term.
Journavx was found to help reduce pain by blocking pain signals in the peripheral nervous system before pain signals reach the brain.
Reshma Kewalramani, CEO and president of Vertex, called the drug’s approval “a historic milestone” in a statement.
“We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” Kewalramani said.
Wellness news for you: Sign up for ‘s Everyone’s Talking newsletter.
Does Journavx have any known side effects?
The most common reactions study participants experienced after receiving Journavx were itching, muscle spasms and rashes, according to the FDA.
Eric Lagatta covers breaking and trending news for . Reach him at [email protected]
