FDA Approves Amphastar Pharma's Nasal Spray for Opioid Overdose

March 09, 2023

(Reuters) - Amphastar Pharmaceuticals Inc said on Wednesday the U.S. Food and Drug Administration (FDA) had approved its nasal spray for emergency treatment of known or suspected opioid overdose.

The company's naloxone hydrochloride nasal spray can be delivered in one spray by intranasal administration — delivering 4 mg of the drug in adults and pediatric patients — for an initial dosing, according to the FDA label. The regulator's approval allows its use only when prescribed.

The nod comes at a time when the agency is reviewing applications to also allow over-the-counter use of some naloxone-based drugs, including an application for Emergent Biosolutions' Narcan.

Late last year, the health regulator had said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally and encouraging more manufacturers to seek approval for prescription-free use.

More than 106,000 people died in the U.S. from drug-involved overdose in 2021, according to government data.

(Reporting by Raghav Mahobe in Bengaluru; editing by Uttaresh Venkateshwaran)