The Wall Street Journal: Over-the-counter overdose-reversal drug from nonprofit pharma group wins fast-track U.S. review


A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. 

Harm Reduction Therapeutics Inc. said its 3-milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at cost, about $18 a dose. HRT said it plans to produce 2 million doses a year. 

 “Cost and access is what we’re focused on,” said Michael R. Hufford, HRT’s chief executive officer and co-founder.

An expanded version of this report appears at

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