The Food and Drug Administration (FDA) has approved Amphastar’s New Drug Application (NDA) 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.
Naloxone hydrochloride nasal spray is an opioid antagonist designed using the Company’s proprietary nasal delivery device. It is a prescription medication intended for immediate administration as emergency therapy in settings where opioids may be present.
The product is supplied as a carton containing 2 unit-dose devices; each device delivers a single spray containing 4mg of naloxone hydrochloride (equivalent to 3.6mg of naloxone). The device is ready to use and does not require priming or testing prior to administration.
Commenting on the FDA nod, Dr Jack Zhang, Amphastar’s President and Chief Executive Officer, said: “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.”
- Amphastar Pharmaceuticals receives FDA approval for Naloxone Hydrochloride Nasal Spray 4mg. News release. Amphastar Pharmaceuticals. March 8, 2023. Accessed March 9, 2023. https://ir.amphastar.com/websites/amphastar/English/2110/news-detail.html?airportNewsID=fd568d0c-36f7-43b9-a888-87c8afa3e096.
- Naloxone Hydrochloride Nasal Spray. Package insert. Amphastar Pharmaceuticals; 2023. Accessed March 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf.
This article originally appeared on MPR