The FDA’s news release Tuesday praised Rextovy, a new over-the-counter naloxone nasal spray, for helping to “broaden access.” The company that makes it has its own access story.
Amphastar Pharmaceuticals doubled the wholesale price of its injectable naloxone in the back half of 2014 and into early 2015, from about nineteen dollars a dose to roughly forty-one. When Bernie Sanders and Elijah Cummings wrote demanding an explanation, the company’s lawyers blamed raw materials, energy, and labor. New York’s attorney general eventually pried a six-dollar-per-dose rebate out of Amphastar after sustained pressure, and only for one state. That is the access story the agency did not tell.
What it told instead, framed inside the administration’s Great American Recovery Initiative, is that Rextovy joins Narcan and RiVive on the over-the-counter shelf and that broader competition will, on the agency’s reasoning, help bring overdose deaths down further. The molecule is unchanged. The 4-milligram intranasal dose is the one Emergent’s Narcan has carried since its 2015 approval. What is new is the supplier and the third SKU on a shelf that already had two. Acting CDER director Mike Davis called Rextovy an additional option for consumers, and Karen Murry, who runs the Office of Nonprescription Drug Products, added that immediate access to naloxone nasal sprays is essential during an overdose. Both statements would have been just as accurate, in either direction, the morning before the approval as the morning after.
The “more competition” theory has now had three years to work. Emergent BioSolutions launched Narcan over the counter in September 2023 with a manufacturer’s suggested price of $44.99 for a two-dose carton, and at CVS, Walgreens, and Rite Aid it shipped at exactly that price, in the pain-medication aisle. RiVive, from the nonprofit Harm Reduction Therapeutics, came soon after at a lower list price but moved largely through bulk public-health channels rather than the consumer aisle, which is why almost nobody picking up shampoo has seen one. After three years of two-product competition, the publicly listed shelf price is the launch price. A third entry from a company with Amphastar’s documented enthusiasm for raising naloxone prices is not the obvious mechanism by which that finally changes. Rextovy’s own price, notably, was not disclosed in any of the materials accompanying the approval.
The other part the announcement skipped past is the shape of the overdose curve. STAT’s January reporting put U.S. overdose deaths at roughly 73,000 for the twelve months through August 2025, about a 21 percent drop from the prior twelve months and the steepest decline on record. Researchers tracking the curve credit a tangle of causes: a shift in fentanyl supply and potency, expanded treatment access, opioid-settlement money flowing into states, the end of pandemic stimulus, a shrinking pool of people at highest risk, and yes, the cumulative reach of naloxone in EMS, jails, schools, and home medicine cabinets. None of them claim definitive causation. None of them have placed the marginal third over-the-counter SKU on the list. Announcing one as a major access expansion deserves a raised eyebrow.
Murry’s line about immediate access is true on any given Tuesday. The mismatch the announcement skipped is that the FDA approves products and Congress writes price laws, and nobody on Tuesday’s call had the authority to close the gap between Amphastar’s wholesale price and what the retailer rings up. The agency added a third product to a shelf where the existing two have not moved. Whether the third one moves now depends on Amphastar, which on the available record has not been quick to cut naloxone prices without being made to.
None of this argues against the approval. A drug that reverses opioid overdoses ought to be as easy to buy as ibuprofen, and Amphastar has every right to compete for shelf space alongside everyone else. The question is what the FDA is asking this announcement to carry. The administration wanted federal deliverables on the access side; the agency contributed Rextovy. The story underneath, that the retail price of nasal naloxone has held at the launch level through three years of competition, that the declines in overdose deaths sit upstream of nasal-spray supply, and that the new entrant’s last chapter in the naloxone story ran through a Senate letter and a state-level rebate, is not the one the press release wanted to tell.
That one is worth keeping in mind once the headline scrolls past.
Sources
- FDA – FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose (June 16, 2026)
- BioPharma Dive – US lawmakers push Amphastar for answers on naloxone prices
- Emergent BioSolutions – NARCAN Nasal Spray launches over the counter (August 30, 2023)
- WBUR – Over-the-counter Narcan will cost $45 at major retail pharmacies
- STAT – U.S. overdose deaths fell through most of 2025, CDC data says
- Amphastar Pharmaceuticals – Rextovy product page