The Food and Drug Administration has granted over-the-counter (OTC) approval to Rextovy, a 4 mg naloxone nasal spray product manufactured by Amphastar Pharmaceuticals. The agency announced its decision June 16, nearly three years after its last OTC naloxone approval. Rextovy is the third naloxone product to switch from prescription to OTC, a move that will help incrementally lower the retail price of a medication that should be available to the public for free.
“Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose,” the FDA stated in its announcement. “Rextovy is an additional life-saving medication approved by the FDA to reverse an opioid overdose to be sold directly to consumers and contains the same active ingredient as other naloxone nasal sprays. The availability of multiple approved formulations expands access and market availability, encourages competition that may reduce cost, and offers alternative sourcing options.”
The FDA approved Rextovy as a prescription product in March 2023, about two weeks before it approved Narcan, the 4 mg nasal spray manufactured by Emergent BioSolutions and previously available by prescription, as the first OTC naloxone product. In July 2023 the FDA granted its second OTC approval to RiVive, a 3 mg naloxone nasal spray product from Harm Reduction Therapeutics. Shortly after prescription Rextovy entered the market in early 2024, Amphastar announced that it intended to file an application with the FDA to switch the product to OTC.
Each Rextovy nasal spray delivers a dose of naloxone identical to that of Narcan or any other 4 mg intranasal product. The device itself, however, differs from the widely recognizable design used for Narcan and subsequent opioid overdose antidote products including RiVive, Kloxxado, Rezenopy, Opvee and the various 4 mg generic naloxone nasal sprays.
It’s not clear yet what OTC Rextovy’s retail price will be.
Naloxone was originally only accessible to medical professionals rather than the laypeople who are best-positioned to use it. The prescription version of Narcan was approved as the first naloxone nasal spray product in 2015, and remained the only naloxone nasal spray product until the FDA approved Kloxxado in 2021. In practice, state-wide blanket prescriptions authorized public-health entities to distribute Narcan more like an OTC product than a traditional prescription product, but contracts that favored Narcan over cheaper, generic intramuscular naloxone helped keep naloxone unaffordable for many harm reduction distributors and people who use drugs.
Research has shown limited uptake of OTC naloxone, which makes sense because most people who use it can’t afford to buy it retail. Emergent originally priced OTC Narcan at $44.99 for a two-pack, but competition has slowly made OTC and generic naloxone products cheaper as more of them have entered the market. CalRx, for example, offers its own generic naloxone nasal spray to California residents at $19 for a two-pack.
It’s not clear yet what OTC Rextovy’s retail price will be. GoodRx coupons for the prescription version carried at major pharmacy chains like CVS, Walgreens and Walmart appear to list most prices for a two-pack between $50 and $60, depending on the pharmacy and zip code. The highest prices appear to be $72.24 at CVS and Target across all zip codes.
CVS and Walgreens list Rextovy on their respective websites, but at publication time did not appear to stock it. A Walgreens representative contacted about pricing was unable to locate Rextovy in the pharmacy chain’s online inventory.
OTC Narcan began arriving on pharmacy shelves in September 2023, as the FDA continued to slowly waive remaining regulatory barriers to widespread naloxone access. In May 2024 Walgreens unveiled its own OTC naloxone nasal spray product priced at $34.99 for a two-pack, undercutting OTC Narcan—also stocked at Walgreens—by $10 and likely contributing to Emergent quietly lowering Narcan’s public-interest price (available to authorized syringe service programs and other bulk distributors who give it away for free, as opposed to the higher retail price for individual pharmacy customers) around that same time.
In January 2025 Emergent also acquired the sales and marketing rights for Kloxxado. Though in 2023 naloxone products accounted for more than half of Emergent’s sales, those numbers have steadily diminished even after the addition of Kloxxado. Over the course of 2025 Emergent’s net sales from naloxone products dropped 43 percent, a decrease the company has described as driven “primarily by increased competition.”
Image (cropped) via Food and Drug Administration
