FDA approves nasal-spray version of opioid overdose medication

The Food and Drug Administration today announced the first approved nasal-spray version of naloxone hydrochloride, a medication that can stop or reverse the effects of an opioid overdose. The agency granted fast-track designation and priority review for the nasal spray; previously the drug was only approved in injectable forms. “While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose,” said FDA Acting Commissioner Stephen Ostroff, M.D. Those administering the nasal spray should seek further immediate medical attention for the patient, FDA said, noting that use of the drug in patients who are opioid dependent may result in severe opioid withdrawal.