'Dire public health need': Opioid 'antidote' goes over-the-counter

March 29, 2023
World Net Daily

This story was originally published by the WND News Center.

Narcan, the commercial name for naloxone, is going over-the-counter, with permission from the Food and Drug Administration.

Naloxone counteracts the effects of an opioid overdose, and when administered appropriately, and soon enough, prevents most fatalities from those overdoses.

The FDA announced on Wednesday its decision to make sales of the nasal treatment available over the counter.

The agency said its change in rules paves the way for the "life-saving medication" to be handy when needed.

"The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need," FDA Commissioner Robert Califf said in a statement.

"Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price."

It's been available, through prescription, already since 2015.

Maker Emergent BioSolutions chief Robert G. Kramer noted, "Today’s landmark FDA OTC approval for Narcan Nasal Spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country."

There were more than 101,000 opioid

overdose deaths in the U.S. from October 2021 to October 2022.

Investigative reporter Sharyl Attkisson reported that the FDA, in its announcement, confirmed that the dose available will be a 4-milligram naloxone hydrochloride nasal spray.

"Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose," the FDA said.

The bureaucracy also explained, "The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription."

"Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis," said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in the government announcement.

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