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Nasal spray naloxone one step closer to public availability


June 12, 2015

Easy to use delivery technology could prevent opioid overdose deaths

From concept to medication to treatment graphic

The National Institute on Drug Abuse (NIDA) is pleased to announce that Adapt Pharma Limited, a partner of Lightlake Therapeutics Inc., has commenced a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a nasal spray formulation of naloxone, a drug designed to prevent opioid overdose deaths. A rolling submission allows completed portions of the NDA to be submitted and reviewed by the FDA on an ongoing basis.

NIDA and Lightlake Therapeutics Inc., a biopharmaceutical company developing novel treatments for addiction, entered into a partnership in 2013 to apply new technology towards development of a potentially lifesaving intervention for opioid overdose.

Naloxone can rapidly reverse opioid overdose. The only current FDA approved method of administering naloxone is by injection. An FDA-approved intranasal delivery system could widely expand its availability and use in preventing opioid overdose deaths, a public health problem of epidemic proportion in the U.S.

Read NIDA Director Dr. Nora Volkow’s blog post about naloxone. Learn about overdose death rates

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.

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    NIDA. (2015, June 12). Nasal spray naloxone one step closer to public availability. Retrieved from https://www.drugabuse.gov/news-events/news-releases/2015/06/nasal-spray-naloxone-one-step-closer-to-public-availability

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