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FDA fast-tracks review of over-the-counter opioid overdose antidote

Naloxone has remained an expensive product only available by prescription in most cases.

Published: December 27, 2022 8:49am

Updated: December 27, 2022 9:10am

The U.S. Food and Drug Administration granted priority review status to an over-the-counter naloxone nasal spray to reverse opioid overdoses, the company announced. 

Harm Reduction Therapeutics, a nonprofit pharmaceutical company focused on preventing overdose deaths, announced Monday that the FDA accepted its New Drug Application for the opioid antidote RiVive.

More than 200 Americans died every day last year from opioid overdoses, according to Centers for Disease Control and Prevention data. Naloxone, which was approved by the FDA more than five decades ago to reverse overdoses, has remained an expensive product only available by prescription in most cases. 

The FDA said a preliminary assessment last month found that some naloxone products could be approved for nonprescription use, and Harm Reduction Therapeutics said RiVive is a "direct result" of the FDA's call for over-the-counter naloxone applications.

"When we formed Harm Reduction Therapeutics in 2017, we saw the urgent need to develop an OTC naloxone product, an action that no other company had pursued," Harm Reduction co-founder and CEO Dr. Michael Hufford said. "Now, 5 years later and driven by our success in advancing RiVive toward FDA approval, the public health landscape is beginning to evolve, with OTC naloxone hopefully set to become a reality."

The pharmaceutical company said it expects to hear from the FDA regarding the drug's approval by April 2023.

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