May 31, 2021

FDA Approves Kloxxado for Opioid Overdose

The FDA approved Kloxxado (naloxone hydrochloride) nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

This approval is unique, in that the product comes in an 8 mg dose, while previous naloxone nasal sprays were only approved in 2 mg and 4 mg doses.

According to the drug label, like all naloxone products, Kloxxado is not a substitute for emergency medical care. If a patient is given Kloxxado for an opioid overdose, that patient still requires medical care, as the opioids in that patient’s system may reactivate overdose once the naloxone has run its course. Furthermore, as naloxone negates the effects of opioids, patients who are physically dependent on opioids may enter withdrawal.

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