FDA approves higher dose of Naloxone to treat opioid overdoses


(WTAJ) — The U.S. Food and Drug Administration (FDA) announced the approval of a higher dose of naloxone hydrochloride nasal spray to treat opioid overdose.

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

The spray delivers eight milligrams (mg) of naloxone into the nasal cavity which can be administered by individuals with or without medical training. The FDA previously approved dosages of two mg and four mg in naloxone nasal spray products.

If administered quickly, Naloxone can stop the effects of an opioid overdose within minutes. Using the nasal spray may result in opioid withdrawal symptoms such as body aches, increased heart rate, fever, irritability, increased blood pressure and nausea.

“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 said.

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