The US Food and Drug Administration (FDA) has approved the over-the-counter (OTC), non-prescription use of Harm Reduction Therapeutics’s RiVive, a 3mg naloxone hydrochloride nasal spray, for the emergency treatment of known or suspected opioid overdose.

The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved.

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."

Prescription opioids, such as morphine, codeine and fentanyl, are used as treatments to relax the body and relieve pain.

However, misuse of opioids can lead to several harmful effects, including slowed breathing, and hypoxia, which can ultimately lead to death.

In the US, drug overdoses persist as a major public health issue. In the 12-month period ending in in February 2023, over 105,000 reported fatal overdoses occurred, primarily driven by the use of synthetic opioids.

Naloxone is a medication that is the standard treatment for opioid overdose, as it works to rapidly reverse the opioid overdose effects.

Several steps have been taken by the FDA to help facilitate access to opioid overdose reversal products, decrease unnecessary exposure to opioids, and prevent new cases of addiction.

In March 2023, the FDA approved the first non-prescription naloxone nasal spray, an OTC version of Narcan, as well as the first generic non-prescription naloxone nasal spray product, sANDA, in July 2023.

“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,” Califf said.

In an effort to reduce opportunities for non-medical use, accidental exposure and overdose of opioids, the FDA also initiated its Overdose Prevention Framework, outlining several priorities that are focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the US.

Reference:

https://www.pmlive.com/pharma_news/fda_approves_second_over-the-counter_naloxone_nasal_spray_for_opioid_overdose_1495463