FDA Approves New OTC Drug to Fight Opioid Overdoses
Opioid Overdose Reversal Drug Approved for Prescription-Free Sale
OAN’s Roy Francis
1:54 PM – Saturday, July 29, 2023
The Food and Drug Administration (FDA) has given its approval for the prescription-free sale of an opioid overdose reversal drug manufactured by Harm Reduction Therapeutics.
The drug, known as RiVive, will provide another option for patients in the United States to combat overdose deaths. RiVive is a 3-mg naloxone hydrochloric nasal spray that rapidly reverses the effects of opioids, particularly when administered promptly after the first signs of an overdose.
The FDA Commissioner, Robert M. Califf, MD, stated that this approval is a significant step in protecting public health.
“Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” Califf said in a statement. “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.”
The manufacturer of RiVive has announced that the drug will be available for harm-reduction organizations and state governments across the country as early as next year. Harm Reduction has committed to providing at least 200,000 doses of RiVive free of charge.
Michael Hufford, the co-founder and CEO of the manufacturer, expressed gratitude to the FDA for the approval and emphasized the importance of broad distribution of the drug. He also mentioned that additional funding from partners could help lower the cost of RiVive and increase the amount given away for free.
“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,” Hufford said. “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.”
Harm Reduction Therapeutics is a 501(c)(3) organization funded by private donors and contributors from Purdue Pharma.
In recent years, drug overdose deaths in the United States have reached record highs, surpassing 100,000 in 2021. The Centers for Disease Control and Prevention estimates that around 110,000 Americans died from a drug overdose in 2022.
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