The FDA has approved Rextovy, a new over-the-counter naloxone nasal spray for opioid overdoses.
Consumers will be able to purchase the product without a prescription in stores and online.
The agency says additional OTC options could improve availability, increase competition, and potentially lower costs.
As opioid overdose deaths remain a major public health concern, the U.S. Food and Drug Administration (FDA) has approved another over-the-counter naloxone nasal spray designed to reverse opioid overdoses in emergency situations.
The newly approved product, called Rextovy, joins a growing list of naloxone products that consumers can purchase without a prescription. According to the FDA, expanding access to these medications is part of a broader effort to ensure more people can quickly respond when an overdose occurs.
Naloxone is considered the standard treatment for opioid overdose because it works rapidly to reverse the effects of opioids. The FDA notes that people do not need medical training to administer naloxone, making it a valuable tool for family members, caregivers, bystanders and others who may witness an overdose.
“Reducing opioid overdose deaths is a top priority for FDA,” Mike Davis M.D., Ph.D., acting director of the Center for Drug Evaluation and Research (CDER), said in a news release. “Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives.”
What the FDA approved
The newly approved product, Rextovy, is a 4-milligram naloxone hydrochloride nasal spray intended for the emergency treatment of opioid overdose.
Like other over-the-counter naloxone nasal sprays already on the market, it can be purchased directly by consumers without a prescription. The FDA said consumers will be able to buy it at locations such as pharmacies, convenience stores, and online retailers.
Rextovy contains the same active ingredient found in other naloxone nasal sprays. FDA officials emphasized that having multiple approved products available gives consumers additional choices while helping expand overall access to overdose-reversal medications.
The agency also noted that more products on the market can encourage competition, potentially leading to lower costs and providing alternative sources of supply.
What this means for consumers
For consumers, the approval means there is now another nonprescription option available for responding to an opioid overdose.
People no longer need a prescription to purchase Rextovy, which could make it easier to obtain and keep on hand for emergencies. The FDA says broader availability of naloxone products can help ensure that individuals are prepared to act quickly when an overdose occurs.
“Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available,” Karen Murry, M.D., director of the Office of Nonprescription Drug Products in CDER, said in the release.
“We are proud of the dedicated work our review divisions put into making this approval possible, and we encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”