FDA approves high-dose opioid reversal nasal spray

The U.S. Food and Drug Administration on Friday approved the first high-dose nasal spray for reversing opioid overdoses.

According to a news release, the FDA granted approval to London-based Hikma Pharmaceuticals to market its Kloxxado, a spray containing 8 milligrams of naloxone — double the highest dose currently available.

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Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, typically within minutes. The availability of a higher dose offers an additional treatment option for high-potency overdoses, the agency stated.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the Kloxxado approval “meets another critical need in combatting opioid overdose.”

“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,” Cavazzoni stated.

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