FDA Approves Higher-Dose Injectable Naloxone Product

Adamis Pharmaceuticals Corp. announced on Monday that FDA has approved its high-dose (5 mg/0.5 mL) naloxone injection product to treat opioid overdose.

Adamis is a biopharmaceutical company primarily focused on developing and commercializing therapeutic products for allergy, opioid overdose, respiratory and inflammatory disease. The company said in its news release that the high-dose naloxone product, known as ZIMHI, will be commercially marketed by US WorldMeds, a specialty pharmaceutical organization that develops, licenses and brings healthcare products to market. A full commercial launch is expected in the first quarter of 2022.

“I am pleased to see this much needed high dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl-related deaths,” Dr. Jeffrey Galinkin, an anesthesiologist and former member of the FDA Advisory Committee for Anesthetics, Analgesics and Addiction Products, said in a statement. “The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations.”