The FDA accepts high-dose naloxone nasal spray for opioid overdose


The U.S. Food and Drug Administration (FDA) has approved a higher dose naloxone nasal spray hydrochloride (Kloxxado) for the treatment of known or suspected opioid overdose emergency, as manifested by the respiratory and / or central nervous system depression.

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When given quickly, naloxone can counteract the effects of opioid overdose, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdose, the FDA said in a press release.

“This approval meets another critical need in the fight against opioid overdose,” said Patrizia Cavazzoni, MD, director of the FDA Center for Drug Evaluation and Research.

“Addressing the opiate crisis is one of the FDA’s top priorities and we will continue our efforts to increase access to naloxone and put this important drug in the hands of those who need it most,” Cavazzoni said.

In a company press release announcing the approval, the manufacturer Hikma Pharmaceuticals notes that a recent survey of community organizations in which 4 mg naloxone nasal spray had been distributed showed that for 34% of investment attempts two or more doses of naloxone.

A separate study found that the percentage of calls to emergency medical services related to overdose in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period 2013-2016, which represents an increase of 43% in 4 years.

“The approval of Kloxxado is an important step in providing patients, friends and family, as well as the public health community, with an important new option for treating opioid overdose,” said Brian Hoffmann, president of Hikma Generics, in the statement. .

The company expects Kloxxado to be available in the second half of 2021.

The FDA approved Kloxxado through regulatory route 505 (b) (2), which allows the agency to refer to previous safety and efficacy findings for an already approved product, as well as review the results of other studies on the product.

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