Why NARCAN® Nasal Spray?

NARCAN® (naloxone HCl) Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.3

Prescribe with confidence

NARCAN® (naloxone HCI) 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.3

NARCAN® Nasal Spray is not a substitute for emergency medical care.3 Results may vary. Repeat doses may be necessary.

FACT: NARCAN® Nasal Spray is the most prescribed naloxone formulation in the U.S. 9 out of 10 prescriptions for naloxone are for NARCAN® Nasal Spray.

WITH NARCAN®, HELP REVERSE AN OPIOID OVERDOSE

  • Concentrated 4 mg dose
  • Needle-free; no assembly required
  • Designed for ease-of-use in the community setting
  • 97% of insured lives in the US have coverage for NARCAN® Nasal Spray*
  • Requires no specialized training**

*MMIT Formulary Analytics, July 2018.
**Administer in accordance with Instructions for Use.


NARCAN® NASAL SPRAY PHARMACOKINETIC STUDY

  • 4 mg concentrated dosing designed for effective intranasal delivery
  • Delivers approximately the same amount of naloxone as a 2 mg dose of IM naloxone

Study results

Compared to a 0.4 mg dose of intramuscular (IM) naloxone—the historical standard of care in opioid overdose rescue—NARCAN® Nasal Spray 4 mg shows:

  • Greater Cmax compared to 0.4 mg IM dose3
  • Comparable time to maximal plasma concentration (Cmax)
  • A longer half-life (t1/2)3

*The clinical significance of these results has not been measured and is not known.

Study design

Open-label, randomized crossover study, conducted in the United States, in 30 healthy adult volunteers (18-55 years of age).
Mean ± SD Plasma Concentration of Naloxone.
Based on a pharmacokinetic study comparing a 4 mg single nasal spray versus 0.4 mg intramuscular injection in healthy volunteers.3


Key steps to administering NARCAN® NASAL SPRAY*

PEEL

Peel back the package to remove the device. Hold the device with your thumb on the bottom of the plunger and 2 fingers on the nozzle.

PLACE

Place and hold the tip of the nozzle in either nostril until your fingers touch the bottom of the patient's nose.

PRESS

Press the plunger firmly to release the dose into the patient's nose.

NARCAN® Nasal Spray does not need to be inhaled.

*Administer in accordance with the Instructions for Use. Please refer to the Quick Start Guide.

In a nonrandomized intervention study of naloxone (n=1985), compared with patients who did not receive naloxone, patients who received a naloxone prescription had:4

  • 47% fewer opioid-related emergency department visits per month 6 months after the receipt of the prescription4
  • 63% fewer visits after 1 year4

Design: 2-year nonrandomized intervention study.4

Setting: 6 safety-net primary care clinics in San Francisco, California.4

Intervention: Providers and clinic staff were trained and supported in naloxone prescribing.4

Measurements: Outcomes were proportion of patients prescribed naloxone, opioid-related emergency department (ED) visits, and prescribed opioid dose based on chart review.4

Limitation: Results are observational and may not be generalizable beyond safety-net (closed network) settings.4

INDICATION 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 or to any of the other ingredients.

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.

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 characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

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.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

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.

Please see full Prescribing Information.

References: 1. Hedegaard H, Warner M, Miniño AM. Drug overdose deaths in the United States, 1999–2016. NCHS Data Brief, no 294. Hyattsville, MD: National Center for Health Statistics. 2017/ CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA. 2. Surgeon General’s Advisory on Naloxone and Opioid Overdose. U.S. Department of Health and Human Services. Prevention. Guideline for prescribing opioids for chronic pain. Available at: www.cdc.gov/drugoverdose/prescribing/guideline.html. Accessed May 2018. 3. NARCAN® Nasal Spray. Prescribing Information. Adapt Pharma, Inc. Radnor, PA; 2017. 4. Coffin PO, Behar E, Rowe C, et al. Nonrandomized intervention study of naloxone coprescription for primary care patients receiving long-term opioid therapy for pain. Ann Intern Med. 2016;165(4):245-52. 5. Centers for Disease Control and Prevention. Opioid Overdose. Available at: https://www.cdc.gov/drugoverdose/index.html. Accessed August 12, 2018. 6. World Health Organization. Information Sheet on Opioid Overdose. Available at: http://www.who.int/substance_abuse/information-sheet/en/. Accessed August 12, 2018. 7. Centers for Disease Control and Prevention. Guideline for prescribing opioids for chronic pain. Available at: www.cdc.gov/drugoverdose/prescribing/guideline.html. Accessed August 12, 2018. 8. CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics: 2015. 9. Krieter P, Chiang N, Gyaw S, et al. Pharmacokinetic properties and human use characteristics of an FDA-approved intranasal naloxone product for the treatment of opioid overdose. J Clin Pharmacol. 2016;56(10):1243-53. 10. Mell HK et al. Emergency medical services response times in rural, suburban, and urban areas. JAMA Surg. 2017 Jul 19; [e-pub]. (http://dx.doi.org/10.1001/jamasurg.2017.2230). 11. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Chronic Pain – United States, 2016. Morb Mortal Wkly Rep. 2016;65(1):1-49. 12. National Safety Council. Prescription Opioid Painkiller Public Opinion Poll. October 2017. Available at: NSC.org. 13. CDC Wonder Database Multiple Cause of Death MCD - ICD-10 Codes: T40.1 (Heroin), T40.2 (Other Opioids), T40.3 (Methadone), T40.4 (Other synthetic narcotics) 2013.

INDICATION 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 or to any of the other ingredients.

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.

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 characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

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.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

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.

Please see full Prescribing Information.

References: 1. Hedegaard H, Warner M, Miniño AM. Drug overdose deaths in the United States, 1999–2016. NCHS Data Brief, no 294. Hyattsville, MD: National Center for Health Statistics. 2017/ CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA. 2. Surgeon General’s Advisory on Naloxone and Opioid Overdose. U.S. Department of Health and Human Services. Prevention. Guideline for prescribing opioids for chronic pain. Available at: www.cdc.gov/drugoverdose/prescribing/guideline.html. Accessed May 2018. 3. NARCAN® Nasal Spray. Prescribing Information. Adapt Pharma, Inc. Radnor, PA; 2017. 4. Coffin PO, Behar E, Rowe C, et al. Nonrandomized intervention study of naloxone coprescription for primary care patients receiving long-term opioid therapy for pain. Ann Intern Med. 2016;165(4):245-52. 5. Centers for Disease Control and Prevention. Opioid Overdose. Available at: https://www.cdc.gov/drugoverdose/index.html. Accessed August 12, 2018. 6. World Health Organization. Information Sheet on Opioid Overdose. Available at: http://www.who.int/substance_abuse/information-sheet/en/. Accessed August 12, 2018. 7. Centers for Disease Control and Prevention. Guideline for prescribing opioids for chronic pain. Available at: www.cdc.gov/drugoverdose/prescribing/guideline.html. Accessed August 12, 2018. 8. CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics: 2015. 9. Krieter P, Chiang N, Gyaw S, et al. Pharmacokinetic properties and human use characteristics of an FDA-approved intranasal naloxone product for the treatment of opioid overdose. J Clin Pharmacol. 2016;56(10):1243-53. 10. Mell HK et al. Emergency medical services response times in rural, suburban, and urban areas. JAMA Surg. 2017 Jul 19; [e-pub]. (http://dx.doi.org/10.1001/jamasurg.2017.2230). 11. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Chronic Pain – United States, 2016. Morb Mortal Wkly Rep. 2016;65(1):1-49. 12. National Safety Council. Prescription Opioid Painkiller Public Opinion Poll. October 2017. Available at: NSC.org. 13. CDC Wonder Database Multiple Cause of Death MCD - ICD-10 Codes: T40.1 (Heroin), T40.2 (Other Opioids), T40.3 (Methadone), T40.4 (Other synthetic narcotics) 2013.