FDA Announces Approval of Higher Dose Naloxone

FDA Announces Approval of Higher Dose Naloxone

Naloxone is a drug widely used to treat people suffering an opioid overdose.

There is no question it’s a lifesaver.

Trouble is – as street drugs get more potent, naloxone at currently available dosages doesn’t always help.

And that’s a problem.

The FDA has just approved an 8 mg nasal spray dose of naloxone in the hope of giving first responders another tool to help overdose victims. Until now, 2 mg and 4 mg doses were all that was available.

This action follows FDA requirements that all drug manufacturers of opioid drugs add recommendations about naloxone usage to prescribing information. They also recently extended the allowed shelf-life limits of naloxone nasal spray from two to three years.

Patrice Harris, M.D., chair of the American Medical Association Opioid Task Force had this to say about the FDA’s decision:

By approving a higher dose of naloxone hydrochloride nasal spray product to treat opioid overdose, the FDA is making sure the overdose-reversing drug is potent enough to counteract the increasingly lethal and illicitly manufactured fentanyl and fentanyl analogs. Now, we must make sure that the new version of naloxone is placed on the lowest cost-sharing tier with low or no cost-sharing and also available in pharmacies. Communities are looking for tools to respond to the epidemic of drug overdoses, and the FDA action today adds a powerful one.

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