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The U.S. Food and Drug Administration on Wednesday approved the first nasal spray version of naloxone hydrochloride, better known as Narcan, in hopes that the ease of delivery will help combat the opioid epidemic.
Narcan, which previously was administered by injection, can stop or reverse the effects of an opioid overdose and is carried by many police departments and first responders. Opioids include prescription medications such as oxycodone, hydrocodone, and morphine, as well as heroin.
Hospitals are bearing the cost of drug overdoses, as they don't necessarily receive full reimbursement for treatment.
In 2013, the CDC reported the number of drug overdose deaths had steadily increased for more than a decade. Drug overdose deaths, driven largely by prescription overdoses, are now the leading cause of injury death in the United States, surpassing motor vehicle crashes, according to the FDA.
Until FDA fast-tracked approval, Narcan was only approved in injectable form by syringe or auto-injector. Because of the risk of using a contaminated needle, there's been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally.
"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,"said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration.
Narcan nasal spray is a prescription product that can be used on adults or children and is easily administered.
It is being approved in less than four months, significantly ahead of the product's prescription drug user fee goal date of January 20, 2016.
Narcan nasal spray is distributed by Adapt Pharma of Radnor, Pennsylvania.
The National Institute on Drug Abuse conducted the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. Clinical trials have shown that administering the drug in one nostril delivered the same levels or higher of naloxone as a single dose of a naloxone intramuscular injection, and in approximately the same time frame.