By Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration has approved Vertex Pharmaceuticals’ drug to treat acute pain, the health regulator said on Thursday, offering a first-of-its-kind alternative to addictive opioid painkillers that have fueled a national crisis.
The oral drug, branded Journavx, works by blocking pain signals at their source, unlike opioids — which trigger the brain’s reward centers as they travel through the blood and then attach to neural receptors, leading to addiction and abuse.
Vertex said it has established a U.S. wholesale acquisition cost of $15.50 per 50 milligram pill for Journavx.
Shares of the company rose nearly 4% in extended trading.
“We haven’t had any really new tools come along in a long time,” said Richard Rosenquist, chairman of the Pain Management Department at Cleveland Clinic.
“If this drug comes in, has the drug profile that it has and is in a competitive price bracket, it’s going to rapidly see uptake,” Rosenquist said.
However, questions have been raised on the drug’s commercial potential, as health insurers and hospitals may still prefer to prescribe opioids.
Vertex is focused on getting over the hurdles of insurance coverage and access, Vertex’s Chief Operating Officer Stuart Arbuckle told Reuters ahead of the decision.
The Institute for Clinical and Economic Review (ICER), which is the cost-effectiveness watchdog, said in its draft report that Vertex’s painkiller is cost-effective only at a low price, where the cost savings would be primarily due to averting cases of opioid use disorder.
The FDA’s approval was based on data from two late-stage trials, which showed that the drug significantly reduced surgical pain compared to placebo.
Acute pain is a disabling condition defined as pain lasting less than 3 months.
Vertex estimates that over 80 million people are prescribed a medicine for acute pain every year in the U.S.
In the acute setting, William Blair analyst Myles Minter estimates $3.7 billion in sales for the drug by 2030.
(Reporting by Sriparna Roy and Mariam Sunny in Bengaluru; Editing by Devika Syamnath and Alan Barona)
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