The US FDA has granted approval of Amphastar Pharma’s New Drug Application for naloxone hydrochloride nasal spray 4mg for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression for adult and pediatric patients, according to a company press release.

The drug is delivered by Amphastar’s proprietary nasal delivery device.

Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer commented: “The approval of our naloxone hydrochloride nasal spray marks an important step in helping alleviate the opioids crisis as patients can further broaden their access to a critical product. Utilizing our innovative device platform, the approval of naloxone hydrochloride nasal spray validates our technical capabilities as we can leverage this towards our intranasal pipeline.”

According to IQVIA, the U.S. sales of naloxone hydrochloride nasal spray 4mg in 2022 was approximately $250 million for the 12 months ended December 31, 2022.