FDA approves higher dosage of naloxone nasal spray to combat opioid overdoses


FILE – In this Wednesday, Sept. 11, 2019 file photo, a fire medic holds a box containing naloxone hydrochloride which is carried in all their department’s emergency response vehicles, in Akron, Ohio. Doctors who prescribe opioid painkillers should tell their patients about a potentially life-saving medication that can reverse drug overdoses, according to new federal guidelines issued Thursday, July 23, 2020. (AP Photo/Keith Srakocic)

(WWTI) — On Friday, the United States Food and Drug Administration announced the approval of a higher dose of opioid overdose treatment.

Specifically, the FDA approved the increase dosage of eight milligrams of naloxone hydrochloride nasal spray. Previously the FDA had approved 2 mg and 4 mg of naloxone nasal spray products.

According to the FDA, naloxone administered by individuals, both with or without medical training, to help reduce opioid overdose deaths. If the product is administered quickly, it can county effects opioid overdose effects, usually within minutes.

“Today’s action meets another critical need in combatting opioid overdose,” said FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni, M.D. “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.”

The FDA granted approval of KLOXXADO to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. 

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