throbber
12/15/2019
`
`FDA approves naloxone nasal spray to reverse opioid overdose | National Institute on Drug Abuse (NIDA)
`
`FDA approves naloxone nasal spray to reverse
`opioid overdose
`
`Announcement
`
`November 18, 2015
`
`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.
`
`Pharma, Inc.
`
`Image courtesy of ADAPT
`
`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.
`
`Was this article helpful?
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`https://www.drugabuse.gov/news-events/news-releases/2015/11/fda-approves-naloxone-nasal-spray-to-reverse-opioid-overdose
`
`1/3
`
`Opiant Exhibit 2140
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`

`

`FDA approves naloxone nasal spray to reverse opioid overdose | National Institute on Drug Abuse (NIDA)
`12/15/2019
`Video: Dr. Nora Volkow, NIDA Director
`
`
`
`NIDA’s Dr. Nora Volkow discusses FDA approNIDA’s Dr. Nora Volkow discusses FDA appro……
`
`Video: Dr. Phil Skolnick, Director, Division of Therapeutics and Medical Consequences
`
`
`
`NIDA’s Dr. Phil Skolnick discusses intranasal NIDA’s Dr. Phil Skolnick discusses intranasal ……
`
`Read FDA press release: https://wayback.archive-
`it.org/7993/20180125101447/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc
`m473505.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.
`
`Was this article helpful?
`For more information, contact the NIDA press office at media@nida.nih.gov or 301-443-6245.
`Yes
`No
`
`https://www.drugabuse.gov/news-events/news-releases/2015/11/fda-approves-naloxone-nasal-spray-to-reverse-opioid-overdose
`
`2/3
`
`Opiant Exhibit 2140
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`

`

`FDA approves naloxone nasal spray to reverse opioid overdose | National Institute on Drug Abuse (NIDA)
`
`12/15/2019
`NIDA Press Office
`301-443-6245
`media@nida.nih.gov
`
`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
`
` and website can be found at www.easyread.drugabuse.gov. You can follow NIDA on Twitter
`.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
`
`®
`
`https://www.drugabuse.gov/news-events/news-releases/2015/11/fda-approves-naloxone-nasal-spray-to-reverse-opioid-overdose
`
`3/3
`
`Was this article helpful?
`
`Yes
`
`No
`
`Opiant Exhibit 2140
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 3
`
`

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