Hikma Launches Nasal Naloxone Spray In US

Emergency Opioid Overdose Treatment Approved Through 505(b)(2) Pathway

Hikma has delivered on one of its key US launches for 2021 by introducing its Kloxxado naloxone 8mg nasal spray for the emergency treatment of known or suspected opioid overdose, after the 505(b)(2) product was approved by the FDA earlier this year.

Nose Nasal Nostrils
Hikma has launched its Kloxxado naloxone nasal spray in the US • Source: Alamy

Hikma has delivered on one of its key launches for 2021 by introducing its Kloxxado (naloxone) 8mg nasal spray in the US, for emergency treatment of known or suspected opioid overdose.

When the product was approved by the US Food and Drug Administration through the hybrid 505(b)(2) pathway earlier this year, Hikma noted that it “contains twice as much naloxone per spray as Narcan nasal spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose,” with the product representing “an important new treatment option in addressing the opioid epidemic

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