Adapt Pharma Clarifies Confusion Between NARCAN™ Nasal Spray and Injectable Naloxone Emergency Opioid Treatments

June 6, 2017

NARCAN™ Nasal Spray often used interchangeably and sometimes incorrectly to identify any form of naloxone

Mississauga, Ontario – June 6, 2017: Adapt Pharma Canada, producers of NARCAN™ (naloxone HCl) Nasal Spray 4 mg, a medication used to reverse the effects of an opioid overdose, wants to clarify any confusion surrounding recent news reports that incorrectly identify other forms of naloxone treatments as NARCAN™ Nasal Spray, such as injectable naloxone administered with a needle.1

NARCAN™ is the brand name of the naloxone HCI Nasal Spray 4mg distributed by Adapt Pharma globally. More than 25,000 units have been shipped to over 75 first responders, emergency healthcare officials and harm reduction sites across Canada, including all front-line RCMP officers, over the past six months.

Some recent news reports and product photos have incorrectly identified NARCAN™ Nasal Spray as the injectable application of naloxone (also known as intramuscular or injectable treatment) which requires a syringe and needle. NARCAN™ Nasal Spray has also been misidentified as the needle-based naloxone treatment that has been retrofitted with nasal atomizers.

NARCAN™ Nasal Spray is a ready-to-use, needle-free device that does not require any assembly and no medical training.1 While not a substitute for appropriate medical care, NARCAN™ Nasal Spray delivers a dose of 4mg of naloxone in a concentrated 0.1 ml spray to temporarily reverse an overdose in emergency situations.1

“NARCAN™ Nasal Spray was designed to be easily handled by non-medical personnel, including police officers, firefighters, and friends and family of overdose victims,” said David Renwick, General Manager, Adapt Pharma Canada. “It helps ensure that those who are often the first people on the scene of an overdose can deliver naloxone in a simple, quick and effective way.”

One of the first emergency measures came from the federal health minister, who signed an Interim Order on July 6, 2016 authorizing the immediate importing and availability of NARCAN™ (naloxone HCl) Nasal Spray 4 mg.2 NARCAN™ Nasal Spray is currently available in Canada without a prescription.2 It is the only intranasal version of naloxone available in Canada.3 Naloxone is also available in Canada as an injection.4

The use of opioids has been noted by the Government of Canada as a serious and growing crisis.5 Opioid overdoses are rising with the combination of prescription opioids (Canada is the second largest consumer globally of legal opioids after the United States) and the flood of illicitly-manufactured and highly potent opioids, such as fentanyl, entering the country. 6

British Columbia declared the opioid crisis a public health emergency in April 2016.7 Alberta has also been hit hard; there were almost 20,000 emergency and urgent care visits related to opioids and other substances of misuse between January 1, 2014 and September 30, 2016.8

 

ABOUT NARCAN™ (naloxone HCl) NASAL SPRAY1

Naloxone Hydrochloride Nasal Spray is a pure opioid antagonist indicated for emergency use outside of a hospital to reverse known or suspected opioid overdose, as manifested by respiratory and/or severe central nervous system depression.

Naloxone Hydrochloride Nasal Spray can be administered by a bystander (non-health care professional) before emergency medical assistance becomes available, but it is not intended to be a substitute for professional medical care. Emergency medical assistance (calling 911) should be requested immediately when an opioid overdose is suspected, before administering naloxone.

In clinical studies, nasal edema, nasal inflammation, nasal dryness, nasal congestion, muscle spasms, musculoskeletal pain, headache, dizziness, constipation, nausea, toothache, rhinalgia, xeroderma, and blood pressure increase were reported.

The availability of NARCAN™ Nasal Spray in Canada under the Interim Order signed by the Minister of Health in July 2016 underpins the goal of Health Canada to expedite community access to naloxone and equip first responders and the general public with the ability to readily and rapidly reverse an opioid overdose.

Adapt Pharma Canada Ltd. has established dedicated distribution channels that allow first responders, public health organizations, and individuals to readily access NARCAN™ Nasal Spray. Adapt Customer Support can be reached at 1-877-870-2726 or by e-mail adaptcanada@customer-support.ca.

Naloxone Hydrochloride Nasal Spray is available as 4 mg/0.1 mL single-dose sprayer, carton of 2 devices.

Please see Indications and Important Safety Information below.

The full product monograph for NARCAN™ Nasal Spray is available at https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf

NARCAN™ NASAL SPRAY IMPORTANT SAFETY INFORMATION1

WARNINGS AND PRECAUTIONS

Serious Warnings/ Precautions

Emergency medical assistance (calling 911) should be requested immediately when an opioid overdose is suspected, before using naloxone.

Individuals with a satisfactory response to an initial dose of naloxone should be kept under continued surveillance.

Caregivers administering naloxone should be prepared to act in response to or assist the patient in cases of potential adverse reactions such as aggressive reactions, convulsions and vomiting. Special attention is warranted if naloxone is administered to a neonate or a pregnant woman.

General

In the absence of opioids, in opioid naïve people, naloxone administration shows essentially no pharmacologic activity. In opioid dependent people, naloxone may trigger an acute opioid withdrawal syndrome.

The effectiveness of naloxone has not been assessed in people with intranasal conditions such as abnormal nasal anatomy, nasal symptoms (i.e., blocked and/or runny nose, nasal polyps, etc.) or in people having a product sprayed into the nasal cavity prior to naloxone administration.

Naloxone does not counteract overdoses due to: barbiturates, benzodiazepines, psychostimulants (e.g., cocaine, amphetamines, methylphenidate, etc.), alcohol, or any other non-opioid drug such as non-opioid tranquilizers, anesthetics or sedatives. Naloxone is not effective against respiratory depression due to non-opioid drugs.

Naloxone Hydrochloride Nasal Spray should be administered with caution to persons who are known or suspected to be physically dependent on opioids.

 

Special Populations

Pregnant Women: There are no adequate and well-controlled studies in pregnant women. Administration of naloxone to an opioid-dependent pregnant woman may induce an acute opioid withdrawal syndrome, which may precipitate preterm labor or fetal distress. Naloxone should be used during pregnancy only if clearly needed.

Nursing Women: It is not known whether naloxone is excreted in human milk. Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels.

Pediatrics: Naloxone administration may cause an acute opioid withdrawal syndrome which may be life threatening in opioid dependent neonates if not recognized and properly treated. Clinical data is limited and naloxone should be administered to a neonate only if clearly needed. As for any use of naloxone, emergency medical assistance should be requested immediately, before administering naloxone in a neonate.

Geriatrics (> 65 years of age): Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Therefore, the systemic exposure of naloxone hydrochloride can be higher in these patients.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    Fax to 1-866-678-6789 (toll-free), or
    Mail to:

    Canada Vigilance Program
    Health Canada, Postal Locator 1908C
    Ottawa, ON
    K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

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For media inquiries:
Amanda Federchuk
416-355-7410
amanda.federchuk@ketchum.com


  1. NARCAN™ Nasal Spray. Product Monograph. Available at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf. Accessed June 2017.
  2. Health Canada. Notice – Availability of Naloxone Hydrochloride Nasal Spray (NARCAN™) in Canada. July 6, 2016. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice-avis-nasal-eng.php. Accessed June 2017.
  3. Government of Canada. Health Canada authorizes use of naloxone nasal spray. October 3, 2016. Available at: http://news.gc.ca/web/article-en.do?nid=1132079. Accessed June 2017.
  4. NARCAN™ Nasal Spray. Product Monograph. Available at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf. Accessed June 2017.
  5. Government of Canada. Joint Statement of Action to Address the Opioid Crisis. November 19, 2016. Available at: https://www.canada.ca/en/health-canada/services/substance-abuse/opioid-conference/joint-statement-action-address-opioid-crisis.html. Accessed June 2017.
  6. Canadian Centre on Substance Abuse. First Do No Harm: Responding to Canada’s Prescription Drug Crisis. March 2013. Available at: http://www.ccsa.ca/Resource%20Library/Canada-Strategy-Prescription-Drug-Misuse-Report-en.pdf. Accessed June 2017.
  7. BC Government. Province health officer declares public health emergency. Available at: https://news.gov.bc.ca/releases/2016HLTH0026-000568. Accessed June 2017.
  8. Alberta Health. Opioids and Substances of Misuse. Alberta Report, 2016 Q4; February 7, 2017. Available at: https://open.alberta.ca/publications/opioids-and-substances-of-misuse-alberta-report. Accessed June 2017.