FDA Approves Higher Dose of Naloxone as Opioids Become Stronger

  • Federal officials have approved a higher dose of naloxone, a medication used to counter opioid overdoses.
  • They say the continued opioid crisis, as well as stronger illegal drugs, made the action necessary.
  • Officials recommend people take training classes so they know how to administer naloxone.

The Food and Drug Administration (FDA) has approved a higher-dose formulation of naloxone hydrochloride nasal spray used to treat opioid overdoses.

Two- and 4-milligram formulations of the product are already available. This new approval doubles the previous high dosage, giving clearance for an 8-milligram formulation of naloxone to hit the shelves.

If administered quickly enough during an opioid overdose, naloxone can counter the opioids’ effects long enough for first responders to arrive and treat someone who’s overdosing.

In a country with an ongoing opioid crisis in which 81,000 people died of a drug overdose in 2020, having naloxone on-hand can save lives.

As opioids have become stronger, higher doses of naloxone are sometimes necessary to elicit those same life-saving effects.

“We are seeing a dramatic rise in fentanyl overdoses,” said Jason Beaman, DO, MPH, executive director of training and education at the National Center for Wellness and Recovery at Oklahoma State University Medicine and the chair of psychiatry and behavioral sciences at Oklahoma State University Center for Health Sciences.

“Fentanyl is incredibly powerful and is a major, if not the major contributor, in opioid overdose deaths,” Beaman said. “In order to overcome this powerful drug, we need high and often multiple doses of naloxone.”

Extensive efforts

The FDA has made strides to make naloxone more accessible in recent years, including approving hand-held injectable naloxone and over-the-counter nasal sprays that anyone can administer if they see someone having an overdose.

“[This] action meets another critical need in combatting opioid overdose,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

Pat Aussem, LPC, associate vice president of consumer clinical content development at Partnership to End Addiction, concurred, while urging the agency and policymakers at large to go further.

“This is one more tool in the toolbox, but so much more is needed to turn the tide on the opioid crisis,” Aussem told Healthline.

“Broader naloxone distribution, affordable and universal access to medications to treat opioid use disorder, holistic, evidence-based treatment addressing physical and mental health issues, other harm reduction measures, and more, are crucial,” Aussem said.

People can pitch in to help combat the opioid crisis by finding a local Narcan training. Narcan is the brand name for naloxone.

At those sessions, people can learn how to recognize an opioid overdose, administer the drug, and get free doses of Narcan to have on-hand.

“A collective public health response is needed to manage this crisis,” Aussem said.

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