Addressing the Opioid Crisis: A New Approval


The FDA approved a higher dose of naloxone to treat opioid overdose deaths.



The US Food and Drug Administration (FDA) has approved a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The freshly approved product delivers 8 mg of naloxone into the nasal cavity, whereas previously FDA-approved products were 2 mg and 4 mg naloxone nasal spray products. This approval reflects the FDA’s commitment to address the opioid crisis.

“Today’s action meets another critical need in combatting opioid overdose,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said to the press. “Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”1

Naloxone, created to help reduce opioid overdose deaths, can be administered by individuals with or without medical training. If is administered promptly, naloxone can counter the overdose effects quickly, even within minutes. The approval of the 8 mg naloxone nasal spray adds another tool in the arsenal of combatting opioid overdoses.

The FDA has recently taken several steps to make naloxone products more widely available, which include: encouraging approval of over-the-counter naloxone products; requiring opioid pain reliever manufacturers to add new recommendations about naloxone to prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months.


1. US Food and Drug Administration. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. News release. April 30, 2021.

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