Second OTC Naloxone Spray For Opioid Overdose Receives FDA Approval

31 Jul 2023 • The US Food and Drug Administration (FDA) has approved ReVive, a 3-mg naloxone hydrochloric nasal spray manufactured by Harm Reduction Therapeutics Inc, for over-the-counter (OTC) nonprescription use.

This marks the second opioid overdose reversal agent to be approved for OTC use. The approval was based on data from a study conducted by the manufacturer, which demonstrated that ReVive's bloodstream levels were similar to those of an approved prescription naloxone product.

The agency approved the first nonprescription naloxone nasal spray product in March 2023, the first generic nonprescription naloxone nasal spray product in July 2023 and over the last year has undertaken new efforts to expand opioid disposal options in an effort to reduce opportunities for nonmedical use, accidental exposure and overdose.

The FDA's decision aims to increase the availability of naloxone to the public and enhance efforts to combat opioid overdoses. The FDA commissioner also encouraged other manufacturers of naloxone products to explore potential nonprescription development programs with the agency.

Source: FDA | Read full story

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