FDA approves a second OTC naloxone nasal spray
The US Food and Drug Administration (FDA) has announced that it has approved RiVive, 3mg naloxone hydrochloride nasal spray for over-the-counter (OTC), non-prescription use for the emergency treatment of opioid overdose.
RiVive is the second non-prescription naloxone product approved by the FDA, potentially increasing non-prescription access to the drug to help with the treatment of opioid overdose in the US, where this remains a major public health issue. In the year ending February 2023, more than 105,000 fatal overdoses were reported in the US as being primarily driven by synthetic opioids including illicit fentanyl.
This approval was based on data from a study submitted by the manufacturer which showed similar levels of RiVive in the bloodstream as similar products that are already approved. The drug has also been demonstrated to be safe and effective for its directed use.
Robert M Califf, MD, FDA commissioner, commented: “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. The agency has long prioritised access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential non-prescription development programmes with the FDA.”
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