FDA approves painkiller designed to eliminate addiction risk associated with opioids

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.

“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.

“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.

The initial concept to focus on pain-signaling proteins came out of research involving people with a rare hereditary condition that causes insensitivity to pain.