FDA approves high-dose opioid reversal nasal spray – KIRO 7 Information Seattle

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The US Food and Drug Administration approved the first high-dose nasal spray to reverse opioid overdoses on Friday.

According to a press release, the FDA has approved London-based Hikma Pharmaceuticals to market its Kloxxado, a spray containing 8 milligrams of naloxone – twice the highest dose currently available.

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Naloxone is a medicine that can be given by people with or without medical training to reduce deaths from opioid overdose. When given quickly, naloxone can counteract the overdose effects of opioids, usually within minutes. The availability of a higher dose offers an additional treatment option for highly potent overdoses, the agency said.

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

“Managing the opioid crisis is a top priority for the FDA. We will continue our efforts to improve access to naloxone and put this important medicine in the hands of those who need it most,” said Cavazzoni.

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