Kloxxado: Nasal Spray Naloxone Launched

Kloxxado, approved by the Food and Drug Administration in April for treatment of opioid overdose (see https://atforum.com/2021/06/naloxone-nasal-spray/), is now officially on the market. And the timing is good; this naloxone 8-mg nasal spray, launched August 4 by manufacturer Hikma Pharmaceuticals, comes at a time when naloxone is in short supply. It is approved for both adult and pediatric patients.

Importantly, Kloxxado contains twice as much naloxone per spray as Narcan, which is important with so much illicit fentanyl causing difficult to reverse overdoses. Sometimes, first responders have to give two doses of the 4-mg Narcan spray. In addition, Narcan is in very short supply.

“Last year, fueled by the COVID-19 pandemic and the increasing prevalence of illicitly manufactured synthetic opioids, the number of Americans who died from a drug overdose rose by nearly 30% to more than 93,000, with approximately 75% of those deaths involving opioids,1” said Desiree Crevecoeur-MacPhail, Ph.D., Assistant Professor of Psychology, Chapman University and former Director of Quality Assurance and Utilization Management for the Los Angeles Centers for Alcohol and Drug Abuse, in press materials for Kloxxado. “There is an urgent need for additional resources to combat this epidemic, and Kloxxado will provide an important new tool for those on the front lines of this fight.”

“Naloxone has long been recognized as an important, safe and effective treatment in the fight against opioid overdose,2 but with the increasing prevalence of illicitly manufactured synthetic opioids, organizations including the CDC, the American Medical Associationand others have noted that a higher dose of naloxone may be required to revive a patient due to their high potency,” said Daniel Buffington, PharmD, MBA, FAPhA, a clinical pharmacology specialist, President and Practice Director at Clinical Pharmacology Service and faculty member at the University of South Florida Colleges of Medicine and Pharmacy, also in press materials for Kloxxado. “As a ready-to-use nasal spray that contains twice as much naloxone per spray than the current standard of care, Kloxxado provides an important new treatment for those suffering from an opioid overdose.”  

In one survey, 34% of attempted overdose reversals with Narcan used two or more doses, and a separate study found that the percent of overdose calls requiring multiple doses had increased 43% during 2013-2016.

“We are committed to ensuring Kloxxado is widely accessible to all who can benefit from it, including patients, friends, family members and the public health community,” said Brian Hoffmann, President, Hikma Generics. “As an experienced provider of addiction therapy treatments and a leading producer of nasal sprays in the US, we are pleased to leverage our capabilities to deliver an important new tool in the fight against opioid overdose.”

Naloxone hydrochloride is an opioid antagonist that reverses opioid effects, including respiratory depression, sedation, and hypotension, by competing for the same receptor sites.

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