US FDA approves first OTC opioid overdose reversal drug

US FDA approves first OTC opioid overdose reversal drug

March 29 (Reuters) – The U.S. Food and Drug Administration on Wednesday approved using Emergent BioSolutions Inc’s (EBS.N) Narcan without a prescription, paving the way for easy availability of the life-saving medication that is used to reverse opioid overdose.

The approval for OTC use of the naloxone-based nasal spray will help align the federal government’s stance with states that have provisions to offer the drug without prescription at pharmacies. Emergent said it will make Narcan available on U.S. shelves and at online retailers by late summer.

Shares of the Maryland-based company rose 4.8% to $9.33 before the bell.

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

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.

FDA’s approval is in line with the unanimous recommendation from its independent panel of advisers in February in favor of allowing OTC use of Narcan.’

While the approval puts Emergent ahead in the OTC product race, analysts have said it is not likely to derive significant sales from the approval.

Benchmark analyst Robert Wasserman said ahead of the approval that Narcan sales peaked in 2020 and have declined since.

In late 2021, FDA approved the first generic version of Narcan, sold by Israeli drugmaker Teva Pharmaceuticals (TEVA.TA).

Emergent reported a 14% decline in 2022 for its nasal naloxone products, compared with a 40% increase in 2021.

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Source: Reuters