FDA Approves High-Dose Naloxone Injection Product for Treatment of Opioid Overdose

Officials with the FDA have approved Zimhi 5 mg/0.5 mL (naloxone HCL Injection, USP; Adamis), a high-dose naloxone injection product, for use in the treatment of opioid overdose.

“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,” said Jeffrey Galinkin, MD, former member of the FDA Advisory Committee for Anesthetics, Analgesics and Addiction Products, in a press release. “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.”

Naloxone is an opioid antagonist that functions by blocking or reversing the effects of the opioid, and it is widely considered the treatment of choice for immediate administration in the event of an opioid overdose. According to statistics published by the CDC, drug overdoses are now the leading cause of death for Americans under 50 years of age, with the largest number of those deaths attributed to powerful synthetic opioids, such as fentanyl.

“We are very excited by this approval and are working with our commercial partner, US WorldMeds, to make this much-needed, lifesaving product readily available to the market,” said “Zimhi provides the highest systemic levels of naloxone compared to any of the nasal or intramuscular products currently available.”

Zimhi is intended to be administered immediately by a caregiver in the event of an opioid emergency. The drug is not a replacement for emergency medical care, and emergency medical help should be sought as soon as possible after administering the first dose of Zimhi, even if the individual wakes up from unconsciousness.

REFERENCE

Adamis receives FDA approval for ZIMHI [news release]. Globe Newswire; October 18, 2021. Accessed October 18, 2021. https://www.globenewswire.com/news-release/2021/10/18/2315581/32832/en/Adamis-Receives-FDA-Approval-for-ZIMHI.html