FDA approves second opioid overdose reversal drug for OTC sales

RiVive is a nasal spray made of naxalone. Its functions are similar to those of Narcan, the first drug the agency approved to be sold without a prescription, less than six months ago.

Rivive, naxalona — Voz Media (Harmreductiontherapeutics.com).

Published by

Verónica Silveri Pazos

1 de agosto, 2023

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The growing crisis of drug overuse deaths in the country prompted the Food and Drug Administration (FDA) to approve a second opioid overdose reversal medication for over-the-counter (OTC) sale without a prescription.

The agency issued a statement announcing that RiVive is a nasal spray made of naloxone hydrochloride that reverses the effects of an opioid overdose and helps counteract a potentially fatal consequence:

Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second over-the-counter naloxone product the agency has approved, helping to increase consumer access to over-the-counter naloxone.

The pharmaceutical company that manufactures it, Harm Reduction Therapeutics, will determine when the drug will be available and its cost:

The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.

Over-the-counter (OTC) sales give consumers the ease of purchasing the drug for nonprescription use while also allowing them to buy it online, at supermarkets and gas stations.

Narcan, the first drug approved only six months ago

The approval of RiVive comes just six months after the FDA approved (in March 2023) Narcan (another nasal spray that reverses the effects of opioid overdose) for over-the-counter sales.

The approval of a second over-the-counter drug to reverse the effects of opioid overdoses highlights the nation's worsening drug abuse crisis. In the statement, the agency says it is taking these steps "to help facilitate access to opioid overdose reversal products and to decrease unnecessary exposure to opioids."

In the 12-month period ending February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids like illicit fentanyl. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.