FDA Approves 5mg Naloxone Hydrochloride Injection to Treat Opioid Overdose

The US Food and Drug Administration (FDA) has approved naloxone hydrochloride injection (ZIMHI) to counteract opioid overdose.

The agent is administered through a single-dose, pre-filled syringe that delivers 5 milligrams of naloxone hydrochloride solution through intramuscular or subcutaneous injection.

The approval was granted to Adamis Pharmaceuticals.

Agent

Previously, the FDA has approved injectable naloxone hydrochloride products in 0.4 mg and 2 mg doses (NARCAN).

The naloxone hydrochloride injection can be administered by individuals with or without medical training to reduce overdose deaths. If administered quickly, the injection can counteract the opioid overdose effects within minutes of administration.

The agent received approval through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. Its approval relied on the previous FDA finding of safety and effectiveness for NARCAN injection to support its approval.

The approval noted that the use of naloxone in patients who are opioid-dependent may result in opioid withdrawal, with rapid onset of symptoms including severe body aches, vomiting, diarrhea, increased heart rates, and fever.