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FDA approves nonprofit's over-the-counter opioid overdose nasal spray

RiVive was approved by the FDA Friday and is expected to be made available by early next year.
FDA approves nonprofit's over-the-counter opioid overdose nasal spray
Posted at 6:48 PM, Jul 28, 2023

The U.S. Food and Drug Administration approved another over-the-counter naloxone nasal spray used to reverse opioid overdose on Friday.

RiVive, made by Harm Reduction Therapeutics, is the second nonprescription naloxone product the FDA has approved. But unlike other opioid overdose products, the 3 milligram treatment will be available for free or low cost, and its sales will bring no profit to its manufacturer.

"We are grateful that FDA granted RiVive approval so we can now achieve what most thought impossible and no other company has: broad delivery of a lower-cost nasal naloxone product without a prescription to save lives that could otherwise be lost to opioid overdose," said Dr. Michael Hufford, co-founder and chief executive officer of Harm Reduction Therapeutics, Inc.

Naloxone products are the standard treatment for rapidly reversing effects of an opioid overdose — a persistent public health issue in the U.S. 

In 2020, nearly 75% of drug overdose deaths involved an opioid, according to CDC data. These types of overdose deaths have increased by more than eight times since 1999, and in the past decade, increases have been significantly linked to synthetic opioids mixed with illicitly manufactured fentanyl.

Because of these increased numbers and risks, the FDA has taken multiple steps to support harm reduction practices, like its work in advancing overdose reversal drugs.

In March, the FDA approved the first over-the-counter naloxone nasal spray, Narcan, and in May, it approved the first nalmefene hydrochloride nasal spray, Opvee. Nalmefene is an opioid receptor antagonist that possesses a longer duration of action than naloxone at the same dose, according to the National Institutes of Health. It requires a prescription, however, and is intended for use in health care and community settings.

The newly approved RiVive, according to Harm Reduction Therapeutics, will be available by early 2024, primarily to harm reduction organizations and state governments. But the nonprofit pharmaceutical company said it's looking for additional funding partners to make RiVive even more accessible.

The nonprofit said it's focused on supplying the cheaper option to communities who need it most, and to start, at least 200,000 doses — which is 10% of its projected first year of product production — will be available for free.

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