FDA approves higher-dose opioid overdose treatment

The Food and Drug Administration has approved a stronger version of a naloxone nasal spray to treat opioid overdoses.

Naloxone is a medication that individuals with or without medical training can administer to help counteract an opioid overdose, often within minutes.

The newly approved product, KLOXXADO by Hikma Pharmaceuticals, delivers 8 milligrams of naloxone through the nose, up from the previously approved 2 mg and 4 mg spray products, the FDA said Friday.

The approval by federal regulators comes amid an increase in reported drug overdose deaths during the pandemic. About 88,000 people died in the U.S. from drug overdoses in the 12-month period that ended in August 2020, the highest number of overdose deaths recorded in a year, the Centers for Disease Control and Prevention said this month.

The FDA in recent years has required drug manufacturers of all opioid pain relievers and opioid use disorder medicines to add to prescription information recommendations about using naloxone to treat an overdose. They also have lengthened the shelf life of naloxone nasal spray from 24 months to 36 months.