Health

FDA OKs New High-Dose Naloxone Product for Opioid Overdose

The US Food and Drug Administration (FDA) has approved a high-dose naloxone injection product for the emergency treatment of opioid overdose.

ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.

Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.

Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.

ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.

In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “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.”

“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,” Galinkin said.

As reported by Medscape Medical News last spring, the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company plans to launch ZIMHI in the first quarter of 2022.

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