FDA approves new painkiller that shows promise and challenges of opioid alternatives

WASHINGTON — Federal officials on Thursday approved a new type of pain drug designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin. Two studies in more than 870 patients with acute pain following 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. “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.” Vertex began researching the drug in the 2000s, when drug overdoses were rocketing upward, principally driven by mass prescribing of opioid painkillers for common ailments like arthritis and back pain. “The new medication has side effect profiles that are inherently, not only different, but don’t involve the risk of substance abuse and other key side effects associated with opioids,” said Dr. Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug's development. “We believe the data reflect a near worst-case scenario for this key pipeline program,” biotechnology analyst Brian Abrahams said in a research note to investors, adding that the results jeopardized estimates that Vertex's pipeline could be worth billions across multiple forms of pain.