Legislation & Public Policy, National News

Nonprofit naloxone maker celebrates FDA approval by donating 200,000 doses

By Lev Facher | Aug. 9, 2023

A nonprofit naloxone manufacturer is celebrating its recent market approval by giving away 200,000 doses of its over-the-counter nasal spray.

Harm Reduction Therapeutics said in a statement that it will donate nearly a quarter-million doses of its new product to the Remedy Alliance, an organization devoted to affordable naloxone access. The announcement comes on the heels of the Food and Drug Administration’s approval of Harm Reduction Therapeutics’ product RiVive, a new nasal naloxone spray used to reverse opioid overdose.

The 200,000-dose donation represents roughly 10% of Harm Reduction Therapeutics’ expected annual production, the nonprofit said.

“We founded Harm Reduction Therapeutics with the singular mission to prevent opioid overdose deaths,” Michael Hufford, the organization’s CEO, said in a statement. “We’re dedicated to making free or low-cost over-the-counter naloxone nasal spray available to the communities who need it most.”

RiVive is the second naloxone product to receive clearance to be sold over the counter. The first, Narcan, received FDA approval in March.

Naloxone is viewed as a critical component of the U.S. response to the opioid epidemic. But its high price has hindered public health agencies and community groups’ efforts to buy and distribute the medication en masse.

The Biden administration has recently made naloxone pricing a focus, convening a meeting of for-profit manufacturers to discuss ensuring the medication is financially accessible. That meeting, however, notably excluded both Remedy Alliance and Harm Reduction Therapeutics.

The meeting came amid continued criticism that focused in particular on Narcan’s manufacturer. The company, Emergent BioSolutions, has long faced criticism for the price of its nasal spray, which currently retails for anywhere between $38 and $124 per two-pack, according to the drug pricing website GoodRx.com. Hufford has said that Narcan’s high price partly inspired his founding the nonprofit, and its development of a largely identical product.

Other manufacturers have also rushed to bring naloxone products to the market, including mechanically complex, high-dose versions that can cost hundreds or even thousands of dollars. A dose of generic, injectable naloxone, by contrast, can cost just a few dollars.