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FDA Fast-Tracks Overdose Drug Naloxone for Use Without Prescription

Photo Caption: The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance. (FDA Building 21 stands behind the sign at the campus's main entrance and houses the Center for Drug Evaluation and Research. The FDA campus is located at 10903 New Hampshire Ave.

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.

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