FDA makes case for certain naloxone to go OTC

The US Food and Drug Administration (FDA) yesterday issued a Federal Register notice,  Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain non-prescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to non-prescription status.

Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects, the FDA said.

Commissioner Dr Roberts Califf noted that is part of the FDA’s efforts to combat the opioid overdose crisis, and said: “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”