FDA Fast-Tracks Approval of Overdose Reversal Drug for OTC Use

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Dec. 27, 2022 – An inexpensive overdose-reversal drug in nasal spray form is being fast-tracked by the FDA for consideration to be sold over-the-counter, its maker, Harm Reduction Therapeutics Inc., announced on Monday.

Federal officials have been calling on pharmaceutical companies to develop over-the-counter versions of the drug naloxone in response to the deadly opioid epidemic. Opioids are involved in 3 out of every 4 overdose deaths in the United States, according to data from the CDC. 

Harm Reduction Therapeutics said in a press release that the nasal spray, called RiVive, produced a three times higher blood level concentration of naloxone than an injectable form. The nasal spray also proved easy to administer by people without medical expertise in simulated emergency overdose situations, the company said.

“Cost and access is what we're focused on,” Michael R. Hufford, Harm Reduction Therapeutics's chief executive officer and co-founder, told The Wall Street Journal.

RiVive will be sold at cost for $18, the Journal reported. Harm Reduction Therapeutics says it will also give away some of its product. (The company received funding from now bankrupt OxyContin maker Purdue Pharma and from opioid settlement funds.)

Earlier this month, Emergent BioSolutions, the maker of the widely known naloxone product Narcan, announced the FDA was fast-tracking its product in an over-the-counter nasal-spray form. The price has not been announced. The injectable version of Narcan costs as low as $37, according to the website GoodRx.

Injectable Narcan is available in most places without a prescription but is sold behind the counter in pharmacies.

Emergent BioSolutions previously said its nasal spray may receive approval by the end of March. Harm Reduction Therapeutics expects the FDA to decide whether to approve RiVive by April 28.