Emergency opioid treatment NARCAN™ Nasal Spray added to NIHB Program in Canada

April 24, 2017

Registered First Nations and recognized Inuit now have access to additional naloxone treatment

Mississauga, Ontario – April 24, 2017 – Adapt Pharma Canada, the makers of NARCAN™ (naloxone) Nasal Spray 4mg, applauds the Canadian government for removing barriers to accessing life-saving naloxone, used to treat opioid overdoses. Health Canada has updated medical coverage under the Non-Insured Health Benefits Program (NIHB) to include NARCAN™ Nasal Spray.

The NIHB is a national program that provides coverage to registered First Nations and recognized Inuit for a specified range of medically necessary items and services that are not covered by other plans and programs. Those eligible under the NIHB Program were previously only able to access the naloxone intramuscular injection. Designed with the general public and communities in mind, NARCAN™ Nasal Spray is a ready-to-use, needle-free alternative to other available opioid overdose emergency treatments.

“It is important for Canadians to have access to emergency naloxone treatment in case of an opioid overdose, and adding NARCAN™ Nasal Spray to the NIHB program makes it more accessible to those who need it,” said David Renwick, General Manager, Adapt Pharma Canada. “NARCAN™ Nasal Spray is one key component in addressing the national opioid crisis. It’s helping police and other first responders across Canada, as well as those in the community who provide emergency treatment to overdose victims.”

NARCAN™ Nasal Spray has been available in Canada since July 6, 2016, when the federal health minister executed an Interim Order for the immediate importing and sale of NARCAN™ Nasal Spray. In October of the same year, NARCAN™ Nasal Spray was approved to be sold without a prescription.

Police departments continue to incorporate NARCAN™ Nasal Spray in response to the worsening crisis and the rise of illicit and lethal opioid drugs. Police officers and other emergency personnel, including firefighters, are using NARCAN™ Nasal Spray to temporarily reverse the effects of opioids in emergency situations. They are also using it in case of accidental contact with opioids, such as fentanyl and carfentanyl.1 Front-line RCMP officers are equipped with NARCAN™ Nasal Spray, as are more than half of all municipal police departments in Ontario and every municipal department in British Columbia.

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 further information or to arrange an interview, please contact:
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 April 2017.