The US Food and Drug Administration approved a new 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 Vertex Pharmaceuticals 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.
Journavx is the first drug to be approved in the new class of pain management medicines, the FDA said in a statement on Thursday.
At a cost of $15.50 per 50mg pill, the drug is expensive, but could spare people from developing addiction.
“We haven’t had any really new tools come along in a long time,” said Richard Rosenquist, the chair 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, Stuart Arbuckle, the company’s chief operating officer, told Reuters ahead of the decision.
The Institute for Clinical and Economic Review (ICER), a 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 three months. More than 80 million people are prescribed a medicine for acute pain every year in the US, according to Vertex estimates.
Article by:Source: Reuters
