First nasal spray helps with drug overdoses

November 20, 2015

Manufactured by Adapt Pharma, Narcan is the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Up until now, naloxone has only been available in an injectable form.

It will now be easier for non-medical professionals to treat opioid overdoses, after FDA quickly approved Narcan nasal spray last week.

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Manufactured by Adapt Pharma, Narcan is the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Up until now, naloxone has only been available in an injectable form.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, MD, acting commissioner of the FDA. “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.”  

The FDA granted fast-track designation and priority review for Narcan nasal spray, allowing it to be approved in less than 4 months.

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Adapt Pharma plans to offer the spray at a discount to emergency workers, firefighters and the police. “Many first responders and primary caregivers….feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally,” according to a statement from FDA.

Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This prescription product can be used on adults or children and is easily administered by anyone, even those without medical training, according to FDA. “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,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research.

The drug is sprayed into one nostril while the patient is lying on his or her back, and can be repeated if necessary. However, it is important to note that it is not a substitute for immediate medical care, and the person administering Narcan nasal spray should seek further immediate medical attention on the patient’s behalf.

In clinical trials conducted to support the approval of Narcan nasal spray, administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

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