FDA Approves ZIMHI to Treat Opioid Overdose

ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.

The FDA has approved ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ZIMHI is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection. It was developed by Adamis Pharmaceuticals.

This is the second product available to treat opioid overdose. Narcan is available as both an injection and a nasal spray, which was approved in 2015.

ZIMHI received approval through the 505(b)(2) approval pathway, which allows review of FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. In this case, Adamis’ application relied, in part, on the FDA’s finding of safety and effectiveness for Narcan injection to support approval.

According to the CDC, drug overdoses resulted in about 96,779 deaths in the United States during the 12-month period ending March 2021, which was a 29% increase over the prior 12-month period. Drug overdoses are now the leading cause of death for Americans under age 50, with more powerful synthetic opioids, like fentanyl and its analogues, responsible for the largest number of those deaths.

“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,” Jeffrey Galinkin, M.D., an anesthesiologist, and former member of the FDA Advisory Committee for Anesthetics, Analgesics