Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, announces the shelf-life extension of Kloxxado® (naloxone HCl) nasal spray 8 mg from 24 to 36 months. Kloxxado® packaging has been updated with 36-month dating, starting with product manufactured in March 2024.

Kloxxado® contains twice as much naloxone per spray as Narcan® Nasal Spray 4 mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important treatment option in addressing the overdose epidemic.1,2

Naloxone has long been recognized as an important, safe and effective treatment in the fight against opioid overdose.3 With the increasing prevalence of illicitly manufactured synthetic opioids, organizations including the CDC4 the American Medical Association5 and others have noted that a higher dose of naloxone may be required to revive a patient experiencing poisoning from illicit fentanyl or other opioids. As a ready-to-use nasal spray that contains twice as much naloxone per spray than Narcan®, Kloxxado® provides an important lifesaving treatment option.1,2

“The shelf-life extension is good news for frontline responders and the thousands of people who carry Kloxxado® and who may need to use it at a moment’s notice to reverse an overdose,” said Dr. Hafrun Fridriksdottir, President, Hikma Generics. “We have a role to play in the fight against illicit fentanyl and as we approach National Overdose Awareness Day on August 31 , it’s gratifying that we are supplying an important medicine that can save lives and help address the deadly overdose epidemic.”

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About Naloxone

Naloxone hydrochloride is a medicine that rapidly reverses an opioid overdose. It can quickly restore normal breathing in someone experiencing an opioid overdose and should be given to any person who shows signs of an opioid overdose or when an opioid overdose is suspected.6

Kloxxado® is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.1 Kloxxado® is not a substitute for emergency medical care.1 Kloxxado® is intended for immediate administration as emergency therapy in settings where opioids may be present.1

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.

Kloxxado® is a registered trademark of Hikma Pharmaceuticals USA Inc.
All other registered trademarks are the property of their respective owners.

Please see the Full Prescribing Information and Medication Guide for Kloxxado® for complete product details.

NOTE: This article was not written by a medical professional and is not intended to substitute for the guidance of a physician. These are not Hikma’s recommendations, but rather facts and data collected from various reliable medical sources. For a full list of resources and their attributing links, see below.

HK-2667-v1

References

  1. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ebf0f833-c1c0-487c-8f29-01fa8c61b6cb&type=display
  2. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a0ebc83d-2892-40de-bc0a-775ce90b30db&type=display
  3. https://pubmed.ncbi.nlm.nih.gov/28722939/
  4. https://archive.cdc.gov/#/details?url=https://emergency.cdc.gov/han/2020/han00438.asp
  5. https://apnews.com/article/opioids-business-health-government-and-politics-8263d4b147b3c6b104346b4ca31c28a3
  6. https://nida.nih.gov/publications/drugfacts/naloxone