Kloxxado Receives FDA Approval for Opioid Overdoses


The U.S. Food and Drug Administration (FDA) approved Kloxxado (naloxone) nasal spray, 8mg, on April 29, 2021. A higher strength than the currently available naloxone nasal sprays, it is indicated for emergency use to counteract the central nervous system (CNS) and respiratory depression associated with an overdose of opioids. Approved for children as well as adults, Kloxxado is given as one spray (8mg) as soon as an overdose is suspected. Emergency medical help should be requested right away. If the patient does not respond, additional doses can be given every two or three minutes before professional assistance arrives. The manufacturer, Hikma, plans a launch in the second quarter of 2021, but pricing has not yet been announced. Two single-dose devices will be dispensed together in one box.

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