FDA Just Made a Huge Move in the World of Painkillers

Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin, the AP reports. The US Food and Drug Administration said it approved Vertex Pharmaceuticals' Journavx for short-term pain that often follows surgery or injuries. It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to both opioids and over-the-counter medications like 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.

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 opioid epidemic is mainly due to illicit fentanyl, not pharmaceutical medicines. 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.

(More painkiller stories.)