FDA Approves First OTC Opioid Overdose Reversal Drug

The U.S. Food and Drug Administration on Wednesday approved the over-the-counter use of Emergent BioSolutions Inc’s Narcan, making it the first opioid overdose reversal drug to be sold nationwide without a prescription.

The approval for OTC use of Narcan, Emergent’s naloxone-based nasal spray, will help increase its availability and align the federal government’s stance with states that have provisions to offer the drug without prescription through a pharmacist.

Naloxone rapidly reverses or blocks the effects of opioids, restoring normal respiration, especially when given within minutes of the first signs of an overdose.

The agency’s decision is in line with the unanimous recommendation of an independent panel of advisers in February in favor of allowing OTC use of the drug.

Drug-related overdose deaths in the United States rose about 15% year-over-year to more than 100,000 in 2021, as per official data.

Shares of the Maryland-based company rose 5.5% before the bell.