The non-opioid drug provides ‘an opportunity to mitigate certain risks associated with using an opioid for pain,’ the FDA says.
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.
“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,” Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
Corrigan-Curay said the agency’s approval of Journavx underscores its commitment “to approving safe and effective alternatives to opioids for pain management.”
The FDA approved the drug for twice-daily use in treating adults with acute pain, according to Vertex. The company said it has established a wholesale acquisition cost of $15.50 per 50-milligram pill for Journavx.
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.
