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Vertex Pharmaceuticals (VRTX+6.40%) stock rose on Friday after the Food and Drug Administration (FDA) approved its new painkiller, the first of its kind approved by regulators.
Journavx, or suzetrigine, was approved for the treatment of adults with moderate-to-severe acute pain, which is usually caused by surgery, illness, or painful medical procedures. More than 80 million people are prescribed medicine for acute pain every year, according to Vertex.
The company said Journavx is the only approved non-opioid painkiller and the first new class of pain medicine approved in more than two decades. Its approval comes after years of research and attempts at developing similar drugs, as well as the opioid crisis. An estimated 81,806 people died from opioid-related overdoses in 2022, according to the Centers for Disease Control.
“With the approval of Journavax, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” Vertex CEO Reshma Kewalramani said in a statement.
Vertex stock climbed almost 5% in trading on Friday. Year-to-date, the stock has increased by more than 13%.
The FDA has approved Journavax to be taken twice per day for adults, with Vertex noting that it’s not known whether or not the painkiller is safe for children. Vertex said it had established a wholesale acquisition cost of $15.50 per 50-milligram pill.
While speaking at the 2025 J.P. Morgan (JPM+0.55%) Healthcare Conference earlier this month, Vertex confirmed it is “launch ready,” with plans to begin selling the drug as soon as it secured FDA approval, according to Fierce Pharma. Vertex has said it expects suzetrigine to benefit from the Non-Opioids Prevent Addiction in the Nation Act, which seeks to expand access to non-opioid treatment.
William Blair analysts led by Myles Minter said in a Friday note that the FDA’s approval is a “large win for Vertex,” but Journavx remains more expensive than generic opioids, which can go for about 50 cents per pill. They expect the painkiller to achieve “blockbuster status,” reaching $1 billion in sales by 2028 and peaking at roughly $4.9 billion in 2031.