FDA Expedites Review Of OD Drug For OTC Sales

The Wall Street Journal reports:

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.

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.

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