The Food and Drug Administration (FDA) on Wednesday approved a nasal spray version of the opioid overdose antidote naloxone (Narcan). Until now, the only approved version of naloxone was injectable, The New York Times reports.
The company that makes the spray, Adapt Pharma, said it will offer the spray at a discount to emergency workers, police and firefighters.
Naloxone is used to reverse overdoses of opioids including prescription medications such as oxycodone, hydrocodone and morphine, as well as heroin. The FDA noted in a press release that if naloxone is administered quickly, it can counter the effects of an opioid overdose, usually within two minutes.
“Combating the opioid abuse epidemic is a top priority for the FDA,” said the agency’s Acting Commissioner, Stephen Ostroff, MD. “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 injectable form of naloxone is generally delivered by syringe or auto-injector. Many first responders and caregivers say the nasal spray will be easier to deliver, and eliminates the risk of a contaminated needle stick. There has been widespread use of unapproved naloxone kits that include an injectable formulation of naloxone, with an atomizer that delivers the drug nasally, the FDA noted. “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,” the agency stated.
The nasal spray does not require assembly, and can be easily administered by anyone, even people without medical training, according to the FDA.
Published
November 2015