The FDA approval was based on the results from a Harm Reduction’ study that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product
FDA clears RiVive nasal spray for OTC use. (Credit: Shahid Abdullah from Pixabay)
The US Food and Drug Administration (FDA) has approved RiVive nasal spray for over-the-counter (OTC), nonprescription use in emergencies to treat known or suspected opioid overdose.
Manufactured by Harm Reduction Therapeutics, ReVive is a 3-mg naloxone hydrochloric nasal spray.
The FDA approval was based on the results from a Harm Reduction’ study that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product.
It has been proven that the medication is both safe and effective when used in accordance with its labelling, the health regulator said.
Additionally, the drug manufacturer offered information demonstrating that patients may use the medication correctly and safely without a doctor’s supervision.
FDA Commissioner Robert Califf said: “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 programs with the FDA.”
RiVive is said to be the second nonprescription naloxone product that the FDA has cleared to help customers access naloxone without a prescription.
According to the US health regulator, Naloxone quickly reverses the effects of opioid overdose and it is known as the standard treatment for opioid overdose.
The FDA has taken several actions to ease access to medications that reverse opioid overdoses, reduce unneeded opioid exposure, and stop the emergence of new opioid addiction cases.
The agency approved the first non-prescription naloxone nasal spray product in March 2023 and the first generic non-prescription naloxone nasal spray product in July 2023.
RiVive is expected to be available in early 2024, primarily to harm-reduction organisations and state governments.
The not-for-profit drug manufacturer is planning to make at least 200,000 doses available for free.