FDA Speeds Approval of Naloxone Nasal Spray

By Pat Anson, Editor

It usually takes years for the Food and Drug Administration to approve a new medication.

But it took less than four months for the agency to give the okay to Narcan, the first FDA approved nasal spray containing naloxone, an emergency life-saving medication that can stop or reverse the effects of an opioid overdose.

Opioids – both legal and illegal – can suppress breathing and cause sleepiness. When someone overdoses on an opioid they may fall asleep and be hard to wake, and their breathing can become shallow or even stop – leading to brain damage or death. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, MD, acting commissioner of the FDA. “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.”  

image courtesy of adapt pharma

image courtesy of adapt pharma

Until now, naloxone was only approved in injectable forms, usually in a syringe or auto-injector. Many first responders and emergency room physicians felt a nasal spray formulation of naloxone would be easier and safer to deliver.

Narcan does not require assembly and delivers a consistent, measured dose of naloxone. It can be used on adults or children, according to the FDA, and is easily administered by anyone. The drug is sprayed into one nostril while the patient is lying on their back, and can be repeated if necessary.

The FDA granted fast track review of Narcan in July after a getting a new drug application from a unit of Adapt Pharma, which is based in Ireland.  In clinical trials, a single 4 mg dose of Narcan delivered the same levels of naloxone in about the same amount of time as an injection.

“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.

The use of Narcan in patients who are opioid dependent may result in severe withdrawal symptoms, such as body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, sweating, nausea or vomiting, shivering and abdominal cramps.

Adapt Pharma says Narcan will be available after the first of the year and will initially have a “public interest price” of $75 for a package of two doses when ordered by public health  organizations.  The company has not disclosed pricing for other purchasers using private insurance or paying in cash.

“Anyone who uses prescription opioids for the long term management of chronic pain, or those who take heroin, are potentially at risk of experiencing a life-threatening or fatal opioid overdose where breathing and heart beat slow or stop,” the company said in a statement.