May 1, 2021 - Health

FDA approves high-dose nasal spray to treat opioid overdoses

Picture of an opened pill bottle with opioid pills out of it
Bottle of Vicodin pills. Photo: Smith Collection/Gado/Getty Images

The Food and Drug Administration on Friday approved a higher dose of naloxone hydrochloride nasal spray to reverse the effects of opioid overdoses.

The big picture: "Experts and patient advocates say the more potent medicine is needed because low-dose naloxone sprays and injections sometimes must be given multiple times to keep someone alive until medical help arrives," AP writes.

Details: The FDA approved Hikma Pharmaceuticals’ Kloxxad0, which has 8 milligrams of nalox0ne. The highest dose available on the market now is 4 milligrams.

  • "If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses," the FDA said.
  • Kloxxado will be sold over-the-counter in packages with two nasal spray devices.
  • Naloxone is a safe medicine and side effects are rare, per the National Institute on Drug Abuse.

What they're saying: "Today’s action meets another critical need in combatting opioid overdose," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

  • "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."

By the numbers: More than 70,000 people died from opioid overdoses in 2019 and 40% of deaths involve prescription opioids, according to the Department of Health and Human Services.

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