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

Amphastar Pharmaceuticals,

08/03/2023 17:11

March 8 (Reuters) - Amphastar Pharmaceuticals Inc
 AMPH.O  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'  EBS.O  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)
 ((Raghav.Mahobe@thomsonreuters.com;))