The U.S. Food and Drug Administration (FDA) on Thursday approved a new non-opioid pill, Journavx, for treating moderate-to-severe acute pain in adults, the first drug of its kind to be approved in more than two decades.
The drug, manufactured by Vertex Pharmaceuticals, reduces pain by blocking pain signals in the peripheral nervous system, unlike opioid drugs—which relieve pain by binding to receptors on nerve cells in the brain and potentially lead to addiction.
The FDA said its approval was based on two randomized trials involving 874 adults who had acute pain due to abdominoplasty—also known as a “tummy tuck”—and a bunion surgery, which showed the drug significantly reduced pain compared to placebo.
Corrigan-Curay said the agency’s approval of Journavx underscores its commitment “to approving safe and effective alternatives to opioids for pain management.”
Reshma Kewalramani, CEO and president of Vertex, estimated that there are around 80 million people in the United States who are prescribed pain relief medication each year.
Of those, about 40 million people are prescribed opioids to manage their pain, according to Vertex. The drugmaker stated that nearly 10 percent of those who are prescribed opioids will use them for an extended period, which may lead to some developing opioid use disorder.
About 85,000 people in the United States develop opioid use disorder every year, the company stated.
Common side effects reported by participants who received Journavx during the trials include itching, muscle spasms, and rashes, according to the FDA. People are advised to avoid consuming food products containing grapefruit when taking the drug, the agency stated.
Vertex said that people with liver problems may be at a higher risk of experiencing side effects from taking Journavx. Pregnant women who are planning to take the drug are also recommended to first consult with their health care providers in order to avoid any potential health risks to their unborn babies. The drugmaker stated that its non-opioid drugs may “temporarily reduce” the chance of patients becoming pregnant.
About 125 million opioid prescriptions were distributed to patients across the United States in 2023, indicating a significant reliance on these medications for treating pain.
The CDC stated that using prescription opioids for an extended period of time could increase the risk of an opioid overdose. The agency also advised people against taking other drugs and sedatives while on prescription opioids.
“When prescribed an opioid, the best approach is to try the lowest possible dose in the smallest quantity,” the CDC stated. “Opioids should only be used for as long as necessary. Generally, for acute pain, opioids are rarely needed for more than 7 days and often for 3 days or less.”
