MARCH 29, 2023

FDA Approves OTC Version of Opioid Overdose Reversal Agent


Originally published by our sister publication Pain Medicine News

The FDA approved the first over-the-counter (OTC) naloxone nasal spray (Narcan, Emergent), an opioid overdose reversal agent.

In February, the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee unanimously voted that the benefit-risk profile of the 4-mg naloxone hydrochloride nasal spray supported its use as a nonprescription opioid overdose reversal agent.

Mostly due to