September 24, 2023

The FDA has approved Narcan for over-the-counter use.

Richard Williams/Bloomberg

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Narcan, a standard treatment for opioid overdoses, will become available in US retail stores later this year, as part of health officials’ efforts to reduce the number of fatal overdoses.

The move should also pave the way for Emergent BioSolutions to grow its sales,
Which produces Narcan.

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On Wednesday, the Food and Drug Administration approved Narcan, a naloxone hydrochloride nasal spray, for over-the-counter use. The treatment was previously only available by prescription.

Emergent BioSolutions stock (ticker: EBS) soared nearly 20% on the news in Wednesday’s premarket trading. The biotech’s stock jumped 5% to $9.38 in afternoon trading. the company declined to respond Baron’s Medicine question.

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The over-the-counter approval of Narcan comes as US health officials continue to address the opioid crisis. According to a February report, more than 80,000 Americans are expected to die of drug overdoses involving opioids in 2021, up from 47,600 in 2017. National Center for Health Statistics.

Robert Califf, an FDA commissioner, said in a news release Wednesday that the authorization of over-the-counter Narcan addresses a “serious public health need.”

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of places where it is available and help reduce opioid overdose deaths across the country.”

The White House in September provided nearly $1.5 billion in funding to states and territories to increase access to substance use disorder treatment, expand access to recovery services, and remove barriers to interventions such as naloxone.

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Narcan works by blocking the effects of an opioid overdose, quickly restoring normal breathing 30 to 90 minutes after administration. However, it is not a cure for opioid use disorder, and it is possible to experience the effects of an overdose after the effects of the nasal spray have worn off, according to the National Institute on Drug Abuse.

This first over-the-counter approval of a naloxone product will dramatically increase access to treatment and potentially boost Emergent’s sales.

“The company will need to be able to rapidly commercialize the over-the-counter product to take advantage of first-in-market advantage,” Benchmark analyst Robert Wasserman wrote in a February 16 note.

On Emergent’s fourth-quarter earnings call on February 27, CEO Robert Kramer estimated that Narcan would generate between $290 million and $310 million. Assuming its over-the-counter acceptance across all customer channels—such as drugstores, convenience stores, grocery stores, among other retailers—in 2023.

The forecast could be called conservative by some, given that the product generated $373.7 million in 2022 and $434.3 million in 2021.

Depending on where it is purchased, an initial dose of Narcan can range from $88 to $143, according to prices listed by Prescription Discount Platform. goodrx, Emergent declined to provide details about the price of the drug in pharmacies.

Narcan will be available on U.S. retail shelves and online by late summer, Emergent said in a news release, accounting for manufacturing changes as well as supply-chain modifications to support nonprescription packaging.

Write to Karishma Vanjani at [email protected]