More Canadian Emergency Personnel Combatting Opioid Overdose Crisis with Nasal Spray Treatment

Over 22,000 units of NARCAN® naloxone Nasal Spray distributed in Canada in less than six months

MISSISSAUGA, ON, Feb. 16, 2017 /CNW/ - Adapt Pharma Canada today announced that 22,000 kits of NARCAN® naloxone Nasal Spray have been shipped in the past six months to more than 75 first responder agencies – primarily law enforcement agencies.

Police departments continue to incorporate NARCAN® 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® to temporarily reverse the effects of opioids in emergency situations.1 They are also using it in case of accidental contact with opioids, such as fentanyl and carfentanyl.1

"Since entering the Canadian market last year, we have been working diligently to move at the speed of this crisis," said David Renwick, General Manager, Adapt Pharma Canada. "Our commitment, as per the federal health minister's urgent request, is to provide access to NARCAN® and to help save as many lives as possible. We'll continue to help address the opioid overdose epidemic by getting emergency treatment in the right hands."

Indicated for emergency use outside of a hospital to reverse known or suspected opioid overdose, NARCAN® provides a 4 mg dose of naloxone concentrated in a small 0.1 milliliter spray.1  Designed with the general public and communities in mind, the product is a ready-to-use, needle-free alternative to other available opioid overdose emergency treatments. On July 6, 2016, the federal health minister executed an Interim Order for the immediate importing and sale of NARCAN®, and on October 3, 2016 NARCAN® Nasal Spray was approved and is now available in Canada without a prescription.2,3

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 increased 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 http://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.

__________________________
1 NARCAN® Nasal Spray. Product Monograph. Available at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf. Accessed February 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 February 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 February 2017.

SOURCE Adapt Pharma



For further information: For further information or to arrange an interview, please contact: Amanda Federchuk, 416-355-7410, amanda.federchuk@ketchum.com


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