FDA Approves Naloxone Nasal Spray to Stop Opioid Overdose

More Than 40 Lives Have Been Saved in Lake County by Naloxone Since Christmas

WASHINGTON, D.C. – U.S. Congressman Robert Dold (IL-10) today released the following statement after it was announced that the U.S. Food and Drug Administration approved Narcan nasal spray, which is the first FDA-approved nasal spray version of naloxone hydrochloride, a life saving medication that can stop or reverse the effects of an opioid overdose:

“Drug overdose deaths are now the leading cause of injury death in the United States, but naloxone has already proven to be a powerful tool for overdose prevention, saving more than 35 lives in Lake County in the last year. As a co-chair of the Suburban Anti-Heroin Task Force, I am thrilled that the FDA has approved this life-saving nasal spray. While there is still much work to be done to combat the underlying issues of drug abuse, this is a positive step forward in the fight against drug abuse, and I remain committed to working with local leaders to curb drug abuse in our community.”

Rep. Dold today met with Chelsea LaLiberte, who founded Live4Lali, an Arlington Heights based organization committed to combatting the growing drug abuse epidemic.  LaLiberte is also a co-founder of the Lake County Opioid Initiative.  The two have been working together to combat combat drug abuse and discussed the FDA approval of the naloxone nasal spray.

From the FDA press release:

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, M.D., acting commissioner, Food and Drug Administration. “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.”  

Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. 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.

Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. 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.

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.

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.

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