12/14/2019
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`Press Announcements > FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
`
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`FDA News Release
`
`FDA moves quickly to approve easy-to-use
`nasal spray to treat opioid overdose
`
`Naloxone in nasal spray form provides important new alternative for family members, first responders
`
`For Immediate Release
`
`November 18, 2015
`
`Release
`
`Today the U.S. Food and Drug Administration approved Narcan nasal spray, 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. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and
`morphine, as well as the illegal drug heroin.
`
`Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in
`the United States – surpassing motor vehicle crashes (https://wayback.archive-
`it.org/7993/20170404214906/http://www-nrd.nhtsa.dot.gov/PUBS/812196.pdf). In 2013, the Centers for Disease
`Control and Prevention reported (https://wayback.archive-
`it.org/7993/20170404214906/http://www.cdc.gov/drugoverdose/data/overdose.html) the number of drug
`overdose deaths had steadily increased for more than a decade. When someone overdoses on an opioid, it can be
`difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical
`intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.
`
`“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 (https://wayback.archive-
`it.org/7993/20170404214906/https://www.nlm.nih.gov/medlineplus/druginfo/meds/a612022.html). Many first
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`https://wayback.archive-it.org/7993/20170404214906/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm
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`1/4
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`Opiant Exhibit 2136
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`

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`12/14/2019
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`Press Announcements > FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
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`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 (https://wayback.archive-
`it.org/7993/20170404214906/http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm) designation and
`priority review (https://wayback.archive-
`it.org/7993/20170404214906/http://www.fda.gov/forpatients/approvals/fast/ucm405405.htm) 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.
`
`“We heard the public call for this new route of administration, and we are happy to have been able to move so
`quickly on a product we are confident will deliver consistently adequate levels of the medication – a critical attribute
`for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation
`and Research.
`
`The National Institute on Drug Abuse (https://wayback.archive-
`it.org/7993/20170404214906/http://www.drugabuse.gov/) played a critical role in the development of Narcan
`nasal spray as well, forming a public-private partnership by designing and conducting the clinical trials required to
`determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. NIDA then
`worked with its private sector partners to obtain FDA approval.
`
`“This easy-to-use intranasal formulation will no doubt save many lives,” said Nora Volkow, M.D., director, National
`Institute on Drug Abuse at the National Institutes of Health. “While prevention is the ultimate goal, the drug’s
`successful development illustrates how public/private scientific partnerships can play an important role in
`responding to a national crisis right now.”
`
`Increasing access to and the use of naloxone is part of the targeted strategy (https://wayback.archive-
`it.org/7993/20170404214906/http://www.hhs.gov/about/news/2015/03/26/hhs-takes-strong-steps-to-address-
`opioid-drug-related-overdose-death-and-dependence.html) that Health and Human Services Secretary Sylvia
`M. Burwell put forward in March to address the opioid epidemic and save lives. In July, addiction and advocacy
`groups called for expanded availability of naloxone during an FDA-sponsored public workshop
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`https://wayback.archive-it.org/7993/20170404214906/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm
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`2/4
`
`Opiant Exhibit 2136
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`

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`12/14/2019
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`Press Announcements > FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
`
`(https://wayback.archive-
`it.org/7993/20170404214906/http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm) exploring the uptake and
`use of the drug.
`
`The use of Narcan nasal spray in patients who are opioid dependent (https://wayback.archive-
`it.org/7993/20170404214906/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2851054/) may result in severe
`opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose,
`sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or
`irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
`
`Narcan nasal spray is distributed by Adapt Pharma, Inc., of Radnor, Pennsylvania.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
`assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological
`products for human use, and medical devices. The agency also is responsible for the safety and security of our
`nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating
`tobacco products.
`
`###
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`Related Information
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`Opioid Medications
`(/7993/20170404214906/https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm)
`Exploring Naloxone Uptake and Use – A Public Meeting
`(/7993/20170404214906/https://www.fda.gov/Drugs/NewsEvents/ucm442236.htm)
`Approved Drugs: Questions and Answers
`(/7993/20170404214906/https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm)
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`3/4
`
`Opiant Exhibit 2136
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 3
`
`

`

`12/14/2019
`
`Press Announcements > FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
`
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`Opiant Exhibit 2136
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 4
`
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