FDA approves new opioid reversal drug.
The FDA Approves Second Drug to Combat Opioid Overdoses
The Food and Drug Administration (FDA) has recently given its approval for a second drug to fight against opioid overdoses. This new drug, called RiVive, has been developed by Harm Reduction Therapeutics and is set to be available over the counter without a prescription starting next year.
A Breakthrough for Harm Reduction Therapeutics
Harm Reduction Therapeutics has become the first nonprofit pharmaceutical company to receive approval for an opioid reversal drug. In a commendable move, the company plans to produce 200,000 doses of RiVive for free.
“Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” stated FDA Commissioner Robert Califf. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
A Growing Crisis
With over 100,000 overdose deaths reported in the United States last year, the need for effective solutions is more pressing than ever. In March 2023, the FDA approved the first over-the-counter naloxone nasal spray, marking a significant step forward in combating opioid overdoses.
According to a study conducted by scientists at the Icahn School of Medicine at Mt. Sinai in New York and the National Institute on Drug Abuse from the National Institutes of Health, men experience overdose deaths at a rate two to three times higher than women across all age brackets, states, and types of drugs.
Overdose deaths have seen a staggering fivefold increase across all demographic categories since 2000, with a significant spike in overdoses since 2019.
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