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FDA Approves New OTC Drug to Fight Opioid Overdoses

A sign for⁢ the Food⁤ And Drug Administration‌ is seen outside of the‍ headquarters on July 20,‌ 2020 in White ‌Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)

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.

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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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