BENGALURU: The US Food and Drug Administration on Wednesday approved over-the-counter (OTC) sales of Emergent BioSolutions Inc’s Narcan, allowing for easier availability of the life-saving medication used to reverse opioid overdoses.
The formal decision makes Narcan the first naloxone-based drug available without a prescription.
Emergent said it will make Narcan available on US store shelves and online retailers by late summer.
“I think it’s a big win. The question now remains about the cost,” said Noa Krawczyk, assistant professor at the NYU Grossman School of Medicine.
The contract drugmaker declined to share details on the price of its OTC version of Narcan.
Currently, a 4-milligram, two-dose pack of the nasal spray has a wholesale price of about $120, according to 46Brooklyn, a drug pricing non-profit.
“For people who need it most, it needs to be at a lower price point than what it is currently available,” said Maryann Mason, associate professor of emergency medicine at Northwestern University.
The approval could allow for access to the drug in areas that have concentrated overdose problems and few pharmacies, she said.
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 Biden administration has been pushing for action, as US drug-related overdose deaths surpassed 100,000 in 2021, according to government estimates. The OTC approval helps align the federal government’s stance with states that already offer the nasal spray without prescription at pharmacies.
The FDA approval followed a unanimous recommendation from its independent panel of advisers backing OTC use of Narcan, while suggesting changes to the drug’s packaging.
Shares of Maryland-based Emergent rose as much as 20.2% to $10.70 in early trading. They were up more than 5% at $9.37 later on Wednesday.
The approval puts Emergent ahead in the OTC product race.
While Benchmark analyst Robert Wasserman, ahead of the FDA green light, noted that Narcan sales had been declining, he added, “I do think there’ll be a big demand for the product and I don’t think it’s going to be too price sensitive right away either.”
Emergent reported a 14% fall in 2022 for its nasal naloxone products, compared with a 40% increase in 2021. In late 2021, FDA approved the first generic version of Narcan, sold by Israeli drugmaker Teva Pharmaceuticals.
The company will have to compete on the price once Narcan begins to face additional OTC competition later this year, said TD Cowen analyst Boris Peaker.
Non-profit Harm Reduction Therapeutics’ application for its OTC naloxone nasal spray is currently under FDA review with a decision expected in July 2023.
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