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NIDA. (2015, November 18). FDA approves naloxone nasal spray to reverse opioid overdose. Retrieved from https://archives.drugabuse.gov/news-events/news-releases/2015/11/fda-approves-naloxone-nasal-spray-to-reverse-opioid-overdose

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Announcement

November 18, 2015

Intranasal NaloxoneImage courtesy of ADAPT Pharma, Inc.

Easy-to-use technology provides alternative to injectable form of lifesaving medication

The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, is pleased to announce that intranasal naloxone –a nasal spray formulation of the medication designed to rapidly reverse opioid overdose – has been approved by the U.S. Food and Drug Administration (FDA). The new technology has an easy-to-use, needle-free design, providing family members, caregivers and first responders with an alternative to injectable naloxone for use during a suspected opioid overdose.

The new technology will be marketed by Adapt Pharma Limited, a partner of Lightlake Therapeutics Inc. NIDA and Lightlake, a biopharmaceutical company developing novel treatments for addiction, entered into a partnership in 2013 to apply new technology towards developing a lifesaving intervention for opioid overdose. The product will be marketed under the brand name NARCAN® Nasal Spray.

In 2013, more than 16,000 people died from a prescription opioid overdose, or approximately 44 people per day. In addition, another 8,000 died from heroin-related overdoses, a rate that has nearly quadrupled between 2002 and 2013. This FDA-approved intranasal delivery system could reduce the thousands of opioid-related deaths each year, and give patients a second chance to enter into long term addiction treatment. Family members can ask their health providers or pharmacists how to obtain the nasal spray, which is expected to be commercially available by early next year.

Video: Dr. Nora Volkow, NIDA Director

Video: Dr. Phil Skolnick, Director, Division of Therapeutics and Medical Consequences

Read FDA press release: https://wayback.archive-it.org/7993/20180125101447/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm

Read NIDA Director Dr. Nora Volkow’s blog.

For more information about prescription drug abuse, go to: https://www.drugabuse.gov/drugs-abuse/prescription-drugs-cold-medicines or the CDC’s prescription drug overdose page. For more information about heroin, go to: https://www.drugabuse.gov/publications/research-reports/heroin/what-can-be-done-for-heroin-overdose.

For more information, contact the NIDA press office at media@nida.nih.gov or 301-443-6245.

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