April 30, 2021

The U.S. FDA has approved Kloxxado™ (naloxone hydrochloride) nasal spray, manufactured by Hikma Pharmaceuticals, for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system (CNS) depression, for adult and pediatric patients. Kloxxado is the first FDA-approved naloxone nasal spray to deliver 8mg per dose – twice the amount delivered by Emergent Biosolutions’ Narcan® (naloxone hydrochloride) 4mg nasal spray.

When an individual overdoses on opioids, this can cause a life-threatening slowdown of breathing (respiratory depression) and brain function (CNS depression). Signs of overdose include vomiting, difficulty breathing, confusion, contracted pupils, loss of conscious, and cold, clammy, blue-tinged skin.

Naloxone products like Kloxxado block and reverse the effects of an opioid overdose, which can save lives in an emergency. Such products may be prescribed to patients on opioids for pain relief, or who have opioid use disorder. In some cases, retail pharmacies may dispense naloxone without a prescription as part of a national effort to make emergency treatment for opioid overdose more accessible.

The FDA approved Kloxxado based on the safety and efficacy of Narcan as well as pharmacokinetic (how a drug moves through the body) data specific to Kloxxado. Recommended dosing is a single spray into one nostril. Emergency medical assistance should be sought immediately after giving the dose. If the patient does not respond or responds and then relapses into respiratory depression, additional doses of Kloxxado can be given using a new nasal spray for each dose. The drug can be administered once every 2-3 minutes until emergency medical assistance arrives.

Hikma plans to launch Kloxxado in the second half of 2021. Pricing is not yet available.

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