The U.S. Food and Drug Administration approved a second over-the-counter drug to combat opioid overdoses, including those caused by fentanyl.
RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray was approved as the second over-the-counter (OTC), nonprescription nasal spray for the treatment of a known or suspected opioid overdose. When the drug will be available and its cost to consumers will be determined by its manufacturer, Harm Reduction Therapeutics.
“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,” FDA Commissioner Robert M. Califf, M.D., said in a statement. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
More than 105,000 fatal overdoses were reported from March 2022 to February 2023, the FDA reported, “which were primarily driven by synthetic opioids like illicit fentanyl.”
Harm Reduction Therapeutics, a 501(c)(3) nonprofit pharmaceutical company, was founded in 2017 “to save lives by making naloxone available over-the-counter for free or at the lowest possible cost. Free from a profit motive, with investors and partners committed to our life-saving mission, our goal is to launch an FDA-approved product as soon as possible,” it states on its website.
The announcement comes after the FDA in March approved Narcan/Naloxone for over the counter use, the brand and generic versions of the medication that’s been found to rapidly reverse the effects of opioid overdoses if administered quickly enough. Naloxone has become the standard treatment for opioid overdoses among law enforcement, emergency response technicians, addiction treatment and medical professionals.
Harm Reduction Therapeutics says that Naloxone has successfully reversed overdoses in 98.8% of cases evaluated by the CDC and that tens of thousands of lives have been saved by it.
Its application for RiVive nasal spray for nonprescription use was approved after data it submitted “showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product,” the FDA said. It also said the nonprofit demonstrated that the drug was safe and effective for use as described in its labeling and that consumers understood how to use it without a health-care professional.
The FDA also this month approved another new drug, sANDA, as the first generic nonprescription naloxone nasal spray product to be available on the market. The application was filed by Padagis US LLC, an Israeli pharmaceutical company, requesting approval to change its prescription marketing status to over the counter marketing status.
Fentanyl remains the No. 1 killer of Americans ages of 18 and 45. According to data analyzed by Families Against Fentanyl, children under 14 are dying at a faster rate from illicit fentanyl poisoning than any other age group.
Recognizing the lethality of the drug, all 50 states and the District of Columbia already have “access laws or alternate arrangements in place that allow persons to obtain naloxone from a pharmacist without an individualized, in-person prescription,” Narcan.com reports.
The majority of states and the District of Columbia also have Naloxone standing orders, which allow adults to purchase the drug from a licensed pharmacy without a prescription, Rehabs.org explains. Most rehab facilities and state health departments also have programs through which Americans can get Naloxone for free.
Here’s how Americans can get it.
The OTC status gives consumers more options to purchase the drug including at convenience stores, grocery stores, gas stations and online, the FDA said.
