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FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

Nov 19, 2015

[From the Office of Health and Constituent Affairs, Food and Drug Administration, U.S. Department of Health and Human Services]

Today FDA approved Narcan nasal spray, 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. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.
This prescription product can be used on adults or children and is easily administered by anyone, even those without medical training. 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.
Until this approval, naloxone was only approved in injectable forms (most commonly delivered by syringe or auto-injector). Many first responders and primary caregivers, however, 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.  The FDA-approved product is one for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.
For more information see the FDA News Release at
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