Washington, United States

The United States Food and Drug Administration (FDA), on Friday (July 28) approved the sale of a second opioid overdose reversal drug called RiVive, said the US government agency, in a statement. It was also the first version of over-the-counter naloxone from a nonprofit company which could lead to cheap and even free doses for those in need.

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Approval of RiVive

The approval of the prescription-free sale of the second opioid overdose reversal drug, RiVive, will provide patients with another over-the-counter option for emergency treatment of known or suspected opioid overdose. 

The US Centers for Disease Control and Prevention (CDC) recommends quickly administering Narcan – the only over-the-counter FDA-approved option until now – which consists of an active drug called naloxone, a life-saving medication and nasal spray used to counter the overdose effects. 

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Narcan, which was approved in March is available in all 50 states and can be procured without a prescription in most states.

Similarly, RiVive, which is also a nasal spray version of the drug naloxone, rapidly reverses or blocks the effects of opioids – especially when administered within minutes of the first signs of an overdose – restoring normal respiration. 

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“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” said FDA Commissioner Robert Califf, in a statement. 

He added, “The agency has long prioritised access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.” 

When will it be available?

The RiVive’s manufacturer Harm Reduction Therapeutics, a nonprofit pharmaceutical company, said that the opioid overdose reversal drug might be available early next year, primarily to harm-reduction organisations and state governments, reported Reuters. The organisation will also make at least 200,000 doses available for free.

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“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,” said co-founder and CEO Michael Hufford, as quoted by the news agency. 

Drug overdose in US

RiVive is the second over-the-counter naloxone product approved by the FDA this year. According to the US government agency, more than 105,000 reported fatal overdoses occurred in the 12-month period ending in February 2023. These deaths have predominantly been attributed to synthetic opioids like illicit fentanyl.

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