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FDA approves naloxone nasal spray to reverse opioid overdose


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: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM473505

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.

NIDA Press Office

About the National Institute on Drug Abuse (NIDA): The National Institute on Drug Abuse (NIDA) is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. Fact sheets on the health effects of drugs and information on NIDA research and other activities can be found at www.drugabuse.gov, which is now compatible with your smartphone, iPad or tablet. To order publications in English or Spanish, call NIDA’s DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-645-0228 (TDD) or email requests to drugpubs@nida.nih.gov. Online ordering is available at drugpubs.drugabuse.gov. NIDA’s media guide can be found at www.drugabuse.gov/publications/media-guide/dear-journalist, and its easy-to-read website can be found at www.easyread.drugabuse.gov. You can follow NIDA on Twitter and Facebook.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH. . .Turning Discovery Into Health®

This page was last updated November 2015

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

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