OTC Naloxone Nasal Spray Gains Priority Review

The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the compound a priority review.

The combination drug-device, which is intended as an emergency treatment for accidental opioid overdose, has the potential to widely expand the availability of naloxone.

The NDA is supported by phase 1 data demonstrating that RiVive produces a three-fold higher systemic exposure with comparable early absorption to the reference naloxone product.

HRT has entered into a commercial supply agreement with a contract manufacturer in anticipation of FDA approval and U.S. launch in early 2024.

The agency is expected to make an approval decision by April 28, 2023.