FDA approves third over-the-counter nasal spray to treat opioid drug overdoses
The FDA said the number of overdose deaths has dramatically decreased since it first approved Narcan in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl.
The Food and Drug Administration approved Tuesday a third over-the-counter version of the naloxone nasal spray, which can be used to reverse an opioid overdose.
The FDA touted the move as one that could save lives and reduce costs by expanding access and market availability of the product and encourage competition, according to The Hill.
The move could save lives because if administered in the first few minutes of an overdose, naloxone can counter the effects of an overdose.
“Reducing opioid overdose deaths is a top priority for FDA,” Mike Davis, acting director of the Center for Drug Evaluation and Research, said in a statement. “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.”
The approval of Rextovy for over-the-counter use makes it the third naloxone spray approved for use without a prescription. Rextovy is a 4 milligram naloxone nasal spray and the prescription version sells for between $44 and $60 per box. It was not clear what the over-the-counter version will sell for.
The FDA said the number of overdose deaths has dramatically decreased since it first approved Narcan in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl.
The FDA warned that people who use Rextovy could experience symptoms when they regain consciousness, such as shaking, sweating or nausea, but the product is safe to use even when it is not clear if opioids are present in the person's system.
Misty Severi is a news reporter for Just The News. You can follow her on X for more coverage.