FDA Approves Rextovy as the Third OTC Nasal Spray Naloxone

On June 16, 2026, the FDA approved the switch of Rextovy (naloxone hydrochloride, naloxone HCl) 4mg nasal spray, manufactured by International Medication Systems (IMS), a subsidiary of Amphastar Pharmaceuticals (AMPH), to over-the-counter (OTC) status. Rextovy was initially approved as a prescription drug (NDA 208969) in March 2023 and has now gained OTC status approximately three years later. This medication is an opioid receptor antagonist, an emergency treatment that reverses the respiratory depression, sedation, and hypotension caused by opioid overdose. Dr. Mike Davis, Acting Director of the FDA's CDER, stated that 'the approval of additional OTC naloxone will promote competition, lower costs, and increase access.'

The U.S. Naloxone OTC Market is Entering a Phase of Competition with Three Products

With the entry of Rextovy, there are now three brands of OTC naloxone nasal spray competing in the market. The first OTC product was Narcan (4mg) from Emergent BioSolutions (EBS), approved in 2023 (priced at $44.99 for a 2-pack), and the second was RiVive (3mg) from the non-profit organization Harm Reduction Therapeutics. Including the prescription market, there are several other products available, such as Kloxxado, Rezenopy, Opvee, and the generic Narcan from Amneal Pharmaceuticals, approved in April 2024. Emergent BioSolutions' naloxone sales decreased by 43% year-over-year in 2025 due to increased competition, indicating that the market has entered a phase of price competition.

Price Strategy Will Be the Decisive Factor in Market Share

The list price for Rextovy as a prescription drug is $50-$60 for a 2-pack based on GoodRx, and it is priced up to $72.24 at CVS and Target. In contrast, OTC Narcan is priced at $44.99, Walgreens' own naloxone is priced at $34.99, and the generic naloxone from CalRx in California is priced at $19. Amphastar has not yet announced the retail price for OTC Rextovy, so a competitive pricing strategy will be a key factor in market penetration. With the availability of the product in pharmacies, convenience stores, and online, an expansion of distribution channels is expected.

Public Health Significance in the Trend of Mitigating the Opioid Crisis

The number of opioid overdose deaths in the United States decreased by approximately 38%, from 111,451 in the 12 months ending August 2023 to 68,632 in the 12 months ending December 2025. The expansion of OTC naloxone is believed to have contributed to this decline, and the approval of the third OTC product is a measure to further enhance access. The U.S. naloxone market is estimated at approximately $607.8 million in 2025, with a compound annual growth rate (CAGR) of 10.4%, and is projected to reach $1.2155 billion by 2032.

Amphastar's Portfolio Diversification and Contribution to Revenue

Amphastar (AMPH) recorded revenue of $171.2 million in the first quarter of 2026, and the consensus revenue for fiscal year 2026 is approximately $756.49 million. In addition to its main products, BAQSIMI (nasal glucagon) and generic Atrovent, the switch of Rextovy to OTC status adds a new revenue stream from retail channels. However, given that it is entering a market with intense price competition, a differentiated distribution strategy and an aggressive pricing policy will be crucial in determining its actual contribution to revenue.