US FDA approves second over-the-counter opioid overdose reversal drug
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[July 29, 2023]
(Reuters) - The U.S. Food and Drug Administration has approved
the prescription-free sale of the second opioid overdose reversal drug,
its manufacturer Harm Reduction Therapeutics said on Friday.
The approval of the drug, called RiVive, will provide patients with
another over-the-counter option in the United States, where drug-related
overdose deaths surpassed 100,000 in 2021.
Harm Reduction said it anticipates that RiVive will be available early
next year, primarily to harm-reduction organizations and state
governments. The not-for-profit drugmaker said it would make at least
200,000 doses available for free.
RiVive is a nasal spray version of naloxone, which rapidly reverses or
blocks the effects of opioids, restoring normal respiration, especially
when given within minutes of the first signs of an overdose.
"If we are able to have partners step forward and help fund our work, we
can further lower the cost of RiVive, or increase the amount that we
give away for free," the company's co-founder and CEO Michael Hufford
said.
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The corporate logo of the U.S. Food and
Drug Administration (FDA) is shown in Silver Spring, Maryland,
November 4, 2009. REUTERS/Jason Reed/File Photo
Emergent BioSolutions received the
health regulator's nod in March for the first OTC version of Narcan,
which is also a naloxone-based spray.
Harm Reduction Therapeutics has partnered with contract drug
manufacturer Catalent Inc to manufacture RiVive.
(Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing
by Pooja Desai)
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