Fact Sheet
`FDA-Approved Nasal Naloxone to Treat Opioid Overdose
`
`that
`
`BACKGROUND: THE OPIOID OVERDOSE EPIDEMIC
`• Opioid abuse in the United States has reached epidemic proportions, with deaths due
`to opioid overdose killing Americans every day.1
`• Naloxone is an antidote that has been used as a pharmaceutical ingredient for more than
`40 years as an emergency treatment to rapidly reverse the life-threatening effects of opioid
`overdose until medical help arrives.2
`• There is broad consensus across the medical, advocacy and government communities
`increased access to naloxone is a critical component of the emergency treatment of
`opioid overdose.3,4,5
`• Historically, naloxone has only been approved by the U.S. Food and Drug Administration (FDA) in
`injectable formulations. However, the FDA recently encouraged innovations in more user-friendly
`naloxone delivery systems, especially those that can be given by consumers outside of healthcare settings.6
`WHAT IS NARCAN® NASAL SPRAY?
`• NARCAN® Nasal Spray is an FDA-approved, needle-free naloxone treatment. It provides emergency treatment of known or suspected opioid overdose
`until emergency medical help arrives. NARCAN® Nasal Spray is not a substitute for emergency care.
`• NARCAN® Nasal Spray rapidly delivers a 4 mg dose of naloxone in a single concentrated 0.1 ml nasal spray from a compact, ready-to-use device.7
`Each package contains two devices.
`• NARCAN® Nasal Spray can be readily administered when an opioid overdose occurs and does not require assembly or specialized training.
`• See below for NARCAN® Nasal Spray indications and important safety information.
`HOW DOES NARCAN® NASAL SPRAY WORK?
`•
`In the case of a known or suspected opioid overdose:
`• Peel back the tab to remove NARCAN® Nasal Spray from its package.
`• Place the device into one nostril.
`• Press the device plunger firmly.
`• Get emergency help right away.
`• While not a substitute for emergency medical care, timely administration of a sufficient dose of NARCAN® Nasal Spray can help rapidly reverse the
`life-threatening breathing difficulties that an opioid overdose may cause until emergency medical care can be administered.
`WHO SHOULD HAVE NARCAN® NASAL SPRAY?
`• NARCAN® Nasal Spray will be available in the coming weeks.
`•
`It may be important for the following groups to have NARCAN® Nasal Spray on hand.
`• Anyone who is taking opioids or at risk of an opioid overdose
`• Friends, family members or acquaintances of someone who may be at risk of an opioid overdose
`• Healthcare professionals
`• First responders, including police, firefighters and EMTs
`• Emergency room personnel
`• Hospital and treatment centers
`Full Prescribing Information for NARCAN® Nasal Spray is available at www.NarcanNasalSpray.com and the FDA website.
`INDICATIONS AND IMPORTANT SAFETY INFORMATION
`INDICATIONS
`NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose,
`as manifested by respiratory and/or central nervous system depression.
`
`NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
`
`NARCAN® Nasal Spray is not a substitute for emergency medical care.
`
`IMPORTANT SAFETY INFORMATION
`NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride.
`
`Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.
`
`Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued
`surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.
`
`©2015 ADAPT Pharma, Inc. NARCAN® is a registered trademark licensed to ADAPT Pharma Operations Limited.
`NAR4-09-15. ADAPT Pharma, Inc. Radnor, PA.
`
`November 2015 • Page 1
`
`Opiant Exhibit 2114
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`

`

`Fact Sheet
`FDA-Approved Nasal Naloxone to Treat Opioid Overdose
`
`Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression
`caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete.
`Larger or repeat doses may be required.
`
`Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid
`withdrawal and acute withdrawal syndrome. In neonates, opioid withdrawal may be life-threatening if not recognized
`and properly treated. Monitor for development of opioid withdraw.
`
`Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV
`effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs
`that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use
`of naloxone hydrochloride.
`
`The following adverse reactions were observed in a NARCAN Nasal Spray clinical study: increased blood pressure,
`®
`musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.
`
`See Instructions for Use and full prescribing information in the use of this product.
`
`To report SUSPECTED ADVERSE REACTIONS, contact Adapt Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226)
`or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
`
`Citations
`
`Centers for Disease Control and Prevention. NCHS Data Brief: Drug-poisoning Deaths Involving Heroin: United States, 2000-2013. 2015.
`Available at: http://www.cdc.gov/nchs/data/databriefs/db190.htm
`
`World Health Organization. Naloxone: A Take-home Antidote to Drug Overdose that Saves Lives. 2014. Available at:
`http://www.who.int/features/2014/naloxone/en/
`
`The White House Office of the Press Secretary. FACT SHEET: Obama Administration Announces Public and Private Sector Efforts to Address
`Prescription Drug Abuse and Heroin Use. 2015. Available at:
`https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector
`
`American Medical Association. The American Medical Association Task Force to Reduce Prescription Opioid Abuse. 2015. Available at:
`http://www.ama-assn.org/ama/pub/advocacy/topics/preventing-opioid-abuse/opioid-abuse-task-force.page
`
`Harm Reduction Coalition. American Medical Association, Harm Reduction Coalition and National Safety Council Urge Increased Focus on
`Overdose Prevention and Treatment. 2014. Available at:
`http://www.aafp.org/dam/AAFP/documents/advocacy/prevention/risk/LT-NGA-HarmReduction-021915.pdf
`
`Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation. Opioid Abuse in the U.S. and HHS Actions
`to Address Opioid-Drug Related Overdoses and Deaths. 2015. Available at: http://aspe.hhs.gov/sites/default/files/pdf/107956/ib_OpioidInitiative.pdf
`
`Data on file. Naloxone-Ph1a-002 CSR.
`
`1 2 3
`
`4 5
`
`6 7
`
`©2015 ADAPT Pharma, Inc. NARCAN® is a registered trademark licensed to ADAPT Pharma Operations Limited.
`NAR4-09-15. ADAPT Pharma, Inc. Radnor, PA.
`
`November 2015 • Page 2
`
`Opiant Exhibit 2114
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`