Amphastar Pharmaceuticals Inc announced that the FDA had cleared its nasal spray for the emergency treatment of known or suspected opioid overdose.
According to the FDA label, the company's naloxone hydrochloride nasal spray may be supplied in one spray by intranasal administration, giving 4 mg of the medicine in adults and paediatric patients for an initial dosage.
The approval comes as the FDA is examining applications to enable the over-the-counter use of various naloxone-based medications, including one for Emergent Biosolutions' Narcan.
Late last year, the health regulator stated that naloxone may be safe and effective for over-the-counter usage in some formulations, possibly opening the way for its nationwide use and prompting additional firms to pursue prescription-free permission.
According to federal figures, more than 106,000 persons died in the United States in 2021 from drug-related overdoses.
Earlier this month, Emergent BioSolutions Inc., the maker of Narcan, a nasal spray form of naloxone, said that the US Food and Drug Administration had granted its application for an over-the-counter version of its popular opioid-reversal nasal spray.
Both of these nasal sprays would help to curb the opioid problem across the country.