The FDA has approved a new drug, Journavx, to treat moderate to severe acute pain. (Photo courtesy of Vertex Pharmaceuticals)
The Food and Drug Administration (FDA) has approved a new class of painkillers for the first time in more than two decades. What's more, this new drug is not opioid-based, like many other painkillers on the market.
The FDA announced Thursday (January 30) approval of a new class of prescription painkillers known as susetrigine, which will be sold under the brand name Journavx.
“Today's approval represents a historic moment for the 80 million Americans who are prescribed this medication each year to treat moderate to severe acute pain,” said Dr. Reshma Kewalramani, CEO and president of Vertex Pharmaceuticals, the drug's maker, in a statement.
According to the statement, Journavx can be used to treat moderate to severe acute pain associated with factors such as physical injury or surgery. Doctors typically treat this type of pain with painkillers or analgesics, which may contain opioids.
Opioids are a class of drugs that act on specific receptors in the brain and body, thereby blocking pain signals. While they can effectively control pain, they can also cause a “high,” or feeling of euphoria. These effects can increase the risk of abuse of the drug and, therefore, lead to dependence, according to the National Institute on Drug Abuse (NIDA).
Opioid addiction, or opioid use disorder, is a public health crisis in the United States. In 2022, 76% of drug overdose deaths involved opioids, which are found in both legally prescribed medications and illicit drugs like heroin, according to the Centers for Disease Control and Prevention (CDC), amounting to 82,000 deaths. The vast majority of opioid overdose deaths involve illicitly produced fentanyl, according to NIDA.
The new drug, suzetrigine, does not cause a high like opioids. Instead, Journavx blocks pain signals at the level of peripheral neurons that sense pain, or nociceptors. These neurons are located in the peripheral nervous system, not the brain, allowing them to provide pain relief without the addiction risk associated with opioids, according to Vertex Pharmaceuticals.
According to the FDA, researchers tested Journavx in 874 participants experiencing acute pain after surgery. Two randomized, double-blind trials were conducted, meaning the drug was randomly assigned to some patients while others received a placebo, and neither doctors nor patients knew who was taking the real drug. Participants could also use ibuprofen, a non-opioid drug, if needed. (Ibuprofen works by interfering with enzymes involved in producing pain signals and inflammation.)
The trials showed that patients taking Journavx experienced significantly greater pain reduction compared to those taking a placebo, according to the FDA. Journavx was only approved for use in adults, and Vertex Pharmaceuticals points out that it is currently unknown whether the drug is safe and effective in children.
The most common side effects of Journavx include itching, rash, muscle cramps, and increased levels of creatine phosphokinase, an enzyme often associated with stress or injury that can be increased by some drugs.
Journavx may also temporarily impair female fertility, reducing the chance of conception during treatment, according to Vertex Pharmaceuticals. Patients concerned about this issue are advised to discuss it with their doctor before starting the drug.
“Today’s approval marks an important public health milestone for the treatment of acute pain,” Dr. Jacqueline Corrigan-Cooray, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “This new non-opioid analgesic therapeutic class for the treatment of acute pain helps reduce certain risks associated with the use of opioids
Sourse: www.livescience.com
