U.S. FDA approves Amphastar Pharma's nasal spray for opioid overdose

Amphastar Pharmaceuticals Inc announced that the FDA had approved 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 can be delivered in one spray by intranasal administration, delivering 4 mg of the drug in adults and paediatric patients for initial dosing. Only when prescribed by the regulator may it be used.

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.

Amphastar Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing, manufacturing, and marketing: Injectable, intranasal, and inhalation products. Complex medication including biologics that are derived from living cells or organisms, proteins, and interchangeable biosimilars; various innovative drug delivery systems for different routes of administration; and various proprietary products and technological platforms.