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Responding to appeals from addiction and advocacy groups, the FDA has approved a nasal spray version of naloxone hydrochloride, which can stop or reverse the effects of an opioid overdose.
Naloxone previously had been available only in injectable forms. But first responders and others had asked for a formulation that would be easier to administer and that avoided the risk of a contaminated needle stick. The FDA said use of unapproved kits combining the injectable form with an atomizer as a makeshift nasal spray had become widespread. If given quickly, naloxone can counter the overdose effects of prescription opioids and the illegal drug heroin within 2 minutes.
“Combatting the opioid abuse epidemic is a top priority for the FDA,” the agency’s acting administrator, Stephen Ostroff, MD, said in a statement (http://1.usa.gov/1Qv4gU7). “While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
In clinical studies, naloxone nasal spray given in 1 nostril delivered the same drug level as or a higher drug level than a single dose of the FDA-approved naloxone intramuscular injection.