US drug regulator approves first new type of pain pill in more than 20 years
The US medicines regulator approved a new type of pain pill that aims to eliminate the risks of addiction and overdose associated with medications that launched the US into an opioid epidemic more than two decades ago.
The Food and Drug Administration (FDA) said it approved Vertex Pharmaceuticals' Journavx for short-term pain after surgery or injuries, making it the first new pharmaceutical pain treatment in more than 20 years.
It offers an alternative to opioids like Vicodin and OxyContin, as well as over-the-counter medications like ibuprofen and acetaminophen.
However, the medication’s modest effectiveness, lengthy development process, and high cost – it is much more expensive than comparable opioids – underscore the challenges of finding new ways to manage pain.
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'Shows promise'
Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex’s drug provided more relief than a placebo or dummy pill but didn’t outperform a common opioid-acetaminophen combination pill.
“It’s not a slam dunk on effectiveness,” said Michael Schuh of the US-based Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research.
“But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot [of] promise”.
Vertex began researching the drug in the 2000s, when overdoses were rocketing upward, principally driven by mass prescribing of opioid painkillers for common ailments like arthritis and back pain.
Prescriptions have fallen sharply in the last decade, and the current wave of the US opioid epidemic is mainly due to illicit fentanyl, not pharmaceutical medicines.
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Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to opioids' addictive effects.
Vertex’s drug works differently, blocking proteins that trigger pain signals that are later sent to the brain.
"In trying to develop medicines that don’t have the addictive risks of opioid medicines, a key factor is working to block pain signalling before it gets to the brain,” Vertex’s Dr David Altshuler, told The Associated Press last year.
Commonly reported side effects with the drug were nausea, constipation, itching, rash, and headache.
The drug has not been approved in the European Union.
