FDA approves second over-the-counter naloxone spray

July 28 (UPI) -- The U.S. Food and Drug Administration on Friday approved a second over-the-counter naloxone nasal spray as "a powerful tool" to treat opioid overdoses.

The agency gave the OK to RiVive, a 3 milligram naloxone hydrochloride spray manufactured by Harm Reduction Therapeutics.

The Bethesda, Md., non-profit is the second company to receive approval for over-the-counter sales of the drug, which would be available at drug stores, convenience stores, gas stations and online. The FDA approved Narcan for OTC sales in March.

"We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose," FDA Commissioner Robert Califf said. "Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health."

In December, the FDA granted RiVive a priority review due to an "urgent need" in response to the opioid epidemic in the country, said Dr. Michael Hufford, co-founder and CEO of Harm Reduction Therapeutics.

Drug overdose deaths from opioids rose to more than 80,000 in 2021 -- the most recent full year for which there is data -- about double the figure in 2016. The number of deaths was less than 10,000 in 2000, according to the National Center for Health Statistics, a division of the Centers for Disease Control and Prevention.

The FDA said there were more than 105,000 fatal overdoses -- primarily due to synthetic opioids such as fentanyl -- in the 12 months ending in February.

Naloxone, the primary medication in RiVive and Narcan, quickly reverses the effects of opioid overdoses. Data provided to the FDA showed that with RiVive, a similar amount of the medication reaches the blood stream as it does with prescription naloxone.

Harm Reduction Therapeutics said it doesn't intend to profit from the sale of RiVive and it plans to make the nasal spray available for free or at-cost for harm-reduction programs such as the Remedy Alliance.

"We are extremely excited about this," Remedy Alliance tweeted.

Harm Reduction Therapeutics said it plans to put RiVive on store shelves in early 2024.

"Six years of work by Harm Reduction Therapeutics paid off today!" the company tweeted.