<p>The US Food and Drug Administration (FDA) 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.</p><p>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.</p><p>Vertex said it has established a US wholesale acquisition cost of $15.50 per 50 milligram pills for Journavx.</p><p>Shares of the company rose nearly 4 per cent in extended trading.</p><p>"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.</p><p>"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.</p>.US FDA revokes authorisation for four Covid antibody drugs.<p>However, questions have been raised on the drug's commercial potential, as health insurers and hospitals may still prefer to prescribe opioids.</p><p>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.</p><p>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.</p><p>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.</p><p>Acute pain is a disabling condition defined as pain lasting less than 3 months.</p><p>Vertex estimates that over 80 million people are prescribed a medicine for acute pain every year in the US.</p><p>In the acute setting, William Blair analyst Myles Minter estimates $3.7 billion in sales for the drug by 2030.</p>
<p>The US Food and Drug Administration (FDA) 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.</p><p>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.</p><p>Vertex said it has established a US wholesale acquisition cost of $15.50 per 50 milligram pills for Journavx.</p><p>Shares of the company rose nearly 4 per cent in extended trading.</p><p>"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.</p><p>"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.</p>.US FDA revokes authorisation for four Covid antibody drugs.<p>However, questions have been raised on the drug's commercial potential, as health insurers and hospitals may still prefer to prescribe opioids.</p><p>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.</p><p>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.</p><p>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.</p><p>Acute pain is a disabling condition defined as pain lasting less than 3 months.</p><p>Vertex estimates that over 80 million people are prescribed a medicine for acute pain every year in the US.</p><p>In the acute setting, William Blair analyst Myles Minter estimates $3.7 billion in sales for the drug by 2030.</p>