The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for RiVive (naloxone intranasal spray) as an over-the-counter (OTC) emergency treatment for opioid overdose. 

RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. The Company has submitted the NDA for RiVive following the FDA’s notice encouraging pharmaceutical manufacturers to develop new nonprescription naloxone products. 

The NDA is supported by a phase 1 clinical trial which showed that RiVive achieved a 3-fold higher systemic exposure with comparable early absorption to the reference naloxone product. The application also includes data from robust Human Factors Validation work showing that individuals are able to administer RiVive in a simulated emergency overdose situation.

An FDA decision regarding the approval of RiVive is expected to be made by April 28, 2023.

“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. 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,” said Dr Michael Hufford, Co-Founder and CEO at Harm Reduction Therapeutics.

In December 2022, the FDA has also recently accepted for Priority Review the supplemental NDA for Narcan® (naloxone HCl) Nasal Spray as an OTC emergency treatment for known or suspected opioid overdose.

Reference

Harm Reduction Therapeutics’ New Drug Application for RiVive over-the-counter naloxone nasal spray accepted and granted Priority Review by FDA. News release. Harm Reduction Therapeutics. Accessed December 27, 2022. https://www.prnewswire.com/news-releases/harm-reduction-therapeutics-new-drug-application-for-rivive-over-the-counter-naloxone-nasal-spray-accepted-and-granted-priority-review-by-fda-301710002.html.