FDA Approves Drug To Treat Pain Without Opioid Effects

Bruce66423 shares a report from the Associated Press: Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications such as Vicodin and OxyContin. 'It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to opioids and over-the-counter medications such as ibuprofen and acetaminophen. But the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.

Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a 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 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 promise.' The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less.

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 signaling 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.

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