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FDA Approves Narcan Nasal Spray to Prevent Opioid Overdose

November 19, 2015
New formulation prevents or stops accidental opioid and heroin overdoses without the need for an injection.
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The Food and Drug Administration has announced the approval of a new formulation of naloxone, Narcan nasal spray, to reverse the effects of an opioid overdose. The new formulation eliminates the need for needles.

As most pain prescribers are aware, opioid overdose is a major public health problem, accounting for almost 17,000 deaths a year in the United States. As prescription opioids become harder to obtain, manipulate, and abuse, “people who developed a taste for opioids” began turning to the less expensive alternative: heroin.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, MD, acting commissioner, Food and Drug Administration, in a press release.1 “We cannot stand by while Americans are dying." If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

"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,” said Dr. Ostroff.

In April 2014, the FDA  approved Evzio, a hand-held auto-inject version of naloxone that could be used at home. Despite the availablity of Evzio, many prescribers have been reluctant to prescribe rescue medications to patients on chronic opioid therapy. Naloxone laws have been enacted in 25 states across the country. These laws allow protection for first responders—such as police and firefighters—as well as friends, family or clinicians who administer the opioid antagonist in cases of overdose.

As part of a campaign to prevent overdose deaths, the FDA granted fast track designation and priority review for Narcan nasal spray. According to the agency, the new nasal formulation will "eliminate first responders concerns about the risk of a contaminated needle stick injuries" from IV naloxone and the auto-inject formulations.

How it Is Used

The new device does not require assembly and delivers a consistent, measured dose when used as directed, noted the agency. 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, warned the FDA.

In clinical trials, 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, noted the agency

“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 National Institute on Drug Abuse played a critical role in the development of Narcan nasal spray as well, forming a public-private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. NIDA then worked with its private sector partners to obtain FDA approval.

The use of Narcan nasal spray in patients who opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

Narcan nasal spray is distributed by Adapt Pharma, Inc., of Radnor, Pennsylvania.

Good News for Patients and Providers

“This easy-to-use intranasal formulation will no doubt save many lives,” said Nora Volkow, MD, director, National Institute on Drug Abuse at the National Institutes of Health. “While prevention is the ultimate goal, the drug’s successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis right now.”

"This is indeed good news for both the substance abuse community as well as patients that are legitimately prescribed chronic opioid therapy that have predicted and/or unpredicted risks for opioid-induced respiratory depression (OIRD)," Jeffrey Fudin, BS, PharmD, told Practical Pain Management. "Having another FDA approved form of naloxone will help raise patient and community awareness and add another option to the currently FDA-approved auto-injector Evzio."

But prescribers must bear in mind that absorption through the nasal mucosa "could be diminished in certain patients that have compromised nasal vasculature, septal deviations or trauma, nasal congestion from infection, or from snorting glue, or overusing topical nasal decongestants, illicit and prescription drugs,"2 said Dr. Fudin, Clinical Pharmacy Specialist in Pain Management at Samuel Stratton VA Medical Center, in Albany, New York.

Dr. Fudin has been surprised that prescribers have not provided this life-saving drug more regularly to patients, "especially considering AMA’s statement in July 2015 where they supported dual prescribing of naloxone."  Specifically “the AMA encourages physicians to co-prescribe naloxone to their patients at-risk who are taking opioid analgesics”.3

Increasing access to and the use of naloxone is also part a strategy that Health and Human Services Secretary Sylvia M. Burwell put forward in March to address the opioid epidemic and save lives, noted the agency.

How to Talk to Patients

When talking with patients, Eric Ehlenberger, MD, a pain management and addiction specialist in New Orleans, noted that “I emphasize the potential for accidental overdose related to a child or other family member ingesting the patient’s medications when I encourage my patients to fill the naloxone prescription. When that argument fails," he noted, "I point out that accidental pet ingestion is also treatable with naloxone, and it is not unusual for dogs to quickly chomp down on a bottle of spilled pills before they can be stopped. My vet tells me naloxone is effective and safe for dogs and cats."

"Of course, the argument remains for accidental overdose by the patient, but I de-emphasize that because every patient denies that possibility," said Dr. Ehlenberger.

Last updated on: April 28, 2016
Continue Reading:
Intranasal Naloxone for At-home Opioid Rescue