The Food and Drug Administration (FDA) granted priority review to a nasal spray version of naloxone, a lifesaving drug used to halt the effects of opioid overdoses, according to The Wall Street Journal.
Rivive, a three milligram nasal spray version of the drug produced by Harm Reduction Therapies Inc., has a target approval date of April 28 from the FDA, the company said Monday. If approved, the drug will be available without the need for a prescription.
The FDA fast-tracked overdose drug naloxone for use without a prescription https://t.co/3BDbZPs1hf
— The Wall Street Journal (@WSJ) December 26, 2022
In one trial, the spray formulation had triple the concentration in the blood of 36 trial participants than naloxone delivered by injection. Critically, the drug will also be available at a lower price than other comparable products used to treat opioid overdoses: around $18 a dose, the company said.
HRT said it plans to produce about two million doses per year, 10% of which will be given away. The other 90% will go, at cost, to pharmacies and organizations that work with drug users, according to the Journal.
HRT CEO Michael R. Hufford said the company is focused on “cost and access.” (RELATED: Biden Anti-Overdose Grant Sent Money Disproportionately To California, New York, Not Rust Belt)
Narcan producer Emergent Biosolutions Inc. said it has an expected approval date of March 29 for its over-the-counter nasal spray. The prescription version of Emergent’s product costs more than $100 without insurance. Meanwhile, Pocket Naloxone Corp. is awaiting approval for a nasal swab version of the drug, which the company says works faster than the sprays.
All of those solutions will play a role in combating the historic opioid epidemic still devastating Americans. American life expectancy is at a two-decade low, largely thanks to the COVID-19 pandemic but also due to a record-high level of overdose deaths that reached nearly 107,000 last year.
Life expectancy dropped from 77 to 76.4 in 2021, according to the Centers for Disease Control and Prevention (CDC). The agency says most of the increase in overdoses has been driven by a surge in fentanyl-related deaths.