First Anti-Overdose Nasal Spray Gets Green Light

Narcan nasal spray (naloxone hydrochloride) FDA-approved to treat opioid overdose

(RxWiki News) The FDA just approved a first-of-its-kind medication that could cause a blow to one of the leading causes of death in the US.

The new drug is a nasal spray version of naloxone hydrochloride (brand name Narcan nasal spray). Narcan is already approved by the US Food and Drug Administration (FDA) to stop or reverse opioid drug overdose, but its previously approved forms were injectable. Health officials said a nasal spray version of Narcan will be easier to administer, possibly saving more lives.

“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 the FDA’s Center for Drug Evaluation and Research, in a press release.

Opioids are a broad class of drugs. This class includes many prescription painkillers — like morphine, oxycodone and hydrocodone — and illegal drugs like heroin. Drug overdose deaths are the most common type of injury-related death in the US, according to the FDA.

"If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes," according to the FDA.

Because injectable naloxone was previously shown to be effective, the FDA wanted to test whether a nasal spray version would also provide the necessary lifesaving dose. Trials of the nasal spray found that it was as effective as the already-approved injectable naloxone.

Calling opioid overdoses in the US an "epidemic," Stephen Ostroff, MD, acting FDA commissioner, said this approval could save many lives but doesn't quite get to the heart of the issue.

“Combating the opioid abuse epidemic is a top priority for the FDA,” Dr. Ostroff said in a press release. “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.”

Nora Volkow, MD, director of the National Institute on Drug Abuse, said in a press release that preventing drug addiction is the ultimate goal, but the newly approved nasal spray "will no doubt save many lives" in the meantime.

Adapt Pharma, Inc., markets Narcan nasal spray.

Review Date: 
November 19, 2015