The FDA announced today that it approved a higher dose of naloxone hydrochloride nasal spray to treat opioid overdose.
Previously, the FDA had approved 2 mg and 4 mg naloxone nasal spray products, but the newly approved product — Kloxxado from Hikma Pharmaceuticals — delivers 8 mg of naloxone into the nasal cavity, according to an FDA release.
Individuals with or without medical training can administer naloxone to help reduce opioid overdose deaths, as, when administered quickly, the drug can counter the overdose effects within minutes. A higher dose provides an additional option in treating opioid overdose, the FDA said.
Approval (through the FDA’s 505(b) pathway) for Hikma Pharmaceuticals’ higher dose of naloxone follows the FDA’s recent efforts to improve the availability of naloxone products. The agency has encouraged manufacturers to pursue approval of over-the-counter naloxone products, required drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone and extended the shelf life of naloxone nasal spray from 24 months to 36 months.
“Today’s action meets another critical need in combatting opioid overdose,” FDA Center for Drug Evaluation & Research director Dr. Patrizia Cavazzoni said in the release. “Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”
