“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “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.”
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. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.
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. 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.
To read the full FDA news release, visit: