FDA Approves Narcan Nasal Spray to Treat Opioid Overdoses
The Food and Drug Administration (FDA) has announced the approval of Narcan, a nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose.
In 2013, the Centers for Disease Control and Prevention (CDC) reported the number of drug overdose deaths had steadily increased for more than a decade. When a user overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.
Previously, naloxone was only approved for injectable administration. Nasal delivery will enable individuals without medical training to potentially save a life. Additionally, there is no risk of the contamination associated with a needle.
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.
"Combating the opioid abuse epidemic is a top priority for the FDA," Stephen Ostroff, FDA acting commissioner, said in a written statement. "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. Fast track is a process designed to facilitate development and expedite review of drugs intended to treat serious conditions and that demonstrate the potential to address an unmet medical need. The agency's priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Narcan nasal spray is being approved in less than four months, significantly ahead of the product's prescription drug user fee goal date of January 20, 2016.