RiVive is designed to provide access to naloxone without a prescription and is available as 3 mg naloxone hydrochloride nasal spray.
This is the second over-the-counter product with the first nonprescription nasal spray approved in March 2023.
Naloxone rapidly reverses the effects of opioid overdose and is considered as the standard treatment for opioid overdose.
The approval for the product is based on data from a study that demonstrated similar levels of RiVive reaching the bloodstream as an approved prescription naloxone product.
Individuals who are dependent on opioids, upon usage of this spray may show severe opioid withdrawal symptoms characterised by fever, tachycardia, body aches, diarrhea, increased blood pressure.
They may also show symptoms of runny nose, sneezing, goose bumps, sweating, yawning, nausea, nervousness, irritability, shivering, abdominal cramps, and weakness.
FDA commissioner Robert Califf said: “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 nonprescription development programmes with the FDA.”
The manufacturer will determine the cost and the timeline for availability of this nonprescription product.