November 20, 2015
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FDA approves Narcan nasal spray for opioid overdose

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The FDA has approved Narcan in the form of a nasal spray, according to a press release.

Narcan (naloxone hydrochloride, Adapt Pharma) spray can halt or reverse opioid overdose effects, according to the FDA, and can do so within 2 minutes if administered quickly.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication — a critical attribute for this emergency life-saving drug,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release.

The FDA previously granted fast-track designation and priority review for the nasal spray, which is easier to deliver than naloxone by syringe or auto-injector and eliminates the risk of a contaminated needle, according to the agency.

Janet Woodcock

Janet Woodcock

The spray, which does not require assembly, can be administered by anyone and can be used on adults and children by spraying the drug into one nostril while the patient is laying down.

The FDA said that the approval was a priority, citing statistics that drug overdose deaths have surpassed motor vehicle crashes for the leading cause of injury death in the United States.

“Combating the opioid abuse epidemic is a top priority for the FDA,” Stephen Ostroff, MD, acting FDA commissioner, said in the release. “We cannot stand by while Americans are dying. 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.”

Clinical trials demonstrated that the spray delivered similar or higher levels of naloxone in a similar time frame compared with the injection, according to the release.

The agency said that use of the spray may result in opioid withdrawal, which includes symptoms such as "body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure."