FDA Moves to Fast-Track OTC Naloxone for Opioid Overdose
January 17, 2019
(Medscape) – The US Food and Drug Administration (FDA) today announced “unprecedented” steps to support companies in developing over-the-counter (OTC) naloxone to help reduce opioid overdose deaths. “With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last 7 years to nearly 48,000 in 2017, it’s critical that we continue to address this tragedy from all fronts,” FDA Commissioner Scott Gottlieb, MD, said in a statement. This includes new ways to increase availability of naloxone, which typically can counter the overdose effects within minutes when administered quickly, said Gottlieb.