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Adapt Pharma® Welcomes Canadian & Ontario Governments Programs Providing NARCAN™ (naloxone HCl) Nasal Spray Free of Charge to NIHB Clients and All Ontarians through Pharmacies

April 9, 2018

Dublin – April 9, 2018 – Adapt Pharma today welcomed the important steps recently taken by both the Ontario Government, and the Canadian Government to help address the opioid crisis, through free of charge access to NARCAN™ (naloxone hydrochloride) Nasal Spray.  NARCAN™ Nasal Spray is now available free of charge under two different initiatives: 1) the Ontario Naloxone Program for Pharmacies (ONPP), and 2) as an open benefit for clients of the Non-Insured Health Benefits (NIHB) Program.  The improved access driven by these two programs will better help communities address opioid overdose.  Both Canada and the United States have seen a drastic rise in opioid overdoses.

“Pharmacists have a critical role in addressing the opioid crisis and helping prepare their customers for a possible opioid overdose emergency. My personal mission is to make sure the public is knowledgeable and has access to naloxone as necessary, when an opioid prescription is given,” said Mark Barnes, Pharmacist, Respect Rx Pharmasave in Ottawa. “The design of NARCAN™ Nasal Spray provides ease of use for anyone to administer a concentrated dose of naloxone during an opioid overdose.”

The ONPP was originally launched in June 2016, and this recent update makes Ontario the first province in Canada to provide access to NARCAN™ Nasal Spray free of charge to all citizens through pharmacies. NARCAN™ Nasal Spray 4mg is the first and only needle-free formulation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training and is also the highest concentrated dose of intranasal naloxone currently available.

The NIHB is a national program providing coverage to registered First Nations and recognized Inuit for a range of medically necessary items and services that are not covered by other plans and programs.  The improved access to NARCAN™ Nasal Spray 4mg is important because of the disproportionate impact the opioid crisis is having on First Nations communities. Studies from various parts of Canada show that First Nations People are more likely to experience an overdose and call for emergency medical assistance.1

 “Both the Canadian Government and the Ontario Government have continued to demonstrate their leadership in combatting the opioid crisis with these programs,” said Seamus Mulligan, Chairman and CEO of Adapt Pharma. “We are dedicated to expanding affordable access to NARCAN™ Nasal Spray to all settings where opioids are present and all those that may witness an opioid overdose.”

In the United States, 49 states have a standing order that allows NARCAN® Nasal Spray to be purchased directly from a pharmacist without a personal prescription. Adapt Pharma has prioritized efforts to make NARCAN® Nasal Spray accessible and affordable by partnering with all major wholesalers, distributors and retail pharmacies to ensure nationwide availability of the overdose reversal medication.

Canada Information

NARCAN™ 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.

NARCAN™ 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.

NARCAN™ Nasal Spray is available upon consultation with a pharmacist. Always read the label and follow the direction for use.  The full product monograph for NARCAN™ Nasal Spray is available at https://www.narcannasalspray.ca/pdf/en/product_monograph.pdf.

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.

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

To report serious and unexpected side effects, contact ADAPT Pharma Canada Ltd. at 1-844-898-0657 or Health Canada at 1-866-234-2345 or http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php

United States Information

NARCAN® (naloxone HCl) Nasal Spray

NARCAN® Nasal Spray 4mg is the only FDA-approved, needle-free formulation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training and is also the highest concentrated dose of intranasal naloxone currently available. NARCAN® Nasal Spray is not a substitute for emergency medical care, and additional doses of NARCAN® Nasal Spray may be required until emergency medical assistance arrives. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance. Please see U.S. Indications and Important Safety Information below.

Affordable Access and Availability

NARCAN® Nasal Spray is extensively covered by health insurance providers at affordable co-pays. Ninety-five percent of insured lives have access2 and seventy-five percent of co-pays on prescriptions dispensed at retail pharmacies are $10 or less.3 NARCAN® Nasal Spray is available without a personal prescription from retail pharmacies in 49 states.

Adapt Pharma offers a 40 percent discounted Public Interest Price of $37.50 per dose ($75 per carton of two doses) for qualifying government or nonprofit organizations, including law enforcement, firefighters, harm reduction groups, schools and community centers.

Donations and Schools Program

Adapt Pharma has donated more than 40,000 doses of NARCAN® Nasal Spray to community groups, law enforcement, high schools, colleges and universities. This included 5,500 free doses distributed to high schools in 31 states.  In addition, more than 216 colleges and universities in 35 states have participated in the Schools Program since its launch in March 2016.

Adapt Pharma encourages all high schools and Title IV-eligible, degree-granting colleges and universities in the United States to apply for NARCAN® Nasal Spray at www.narcan.com/partnerships. The program will now provide two free cartons to every high school and four free cartons to every Title IV-eligible, degree-granting college and university in the U.S.

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

Important Safety Information

NARCAN® (naloxone HCI) 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 at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf.

For additional information on NARCAN® Nasal Spray, please visit www.NARCAN.com.

For questions regarding NARCAN® Nasal Spray distribution, please call 1-844-4NARCAN (462-7226).

ABOUT ADAPT PHARMA®

ADAPT Pharma® is a privately-held company committed to expanding affordable access to NARCAN® (naloxone HCI) Nasal Spray and to progressing treatment options in the field of addiction. ADAPT Pharma’s company headquarters is in Dublin, Ireland with U.S. headquarters in Radnor, Pennsylvania, and Canadian headquarters in Toronto, Ontario. For more information, please visit www.adaptpharma.com.

ADAPT PHARMA® MEDIA CONTACT INFORMATION
Thom Duddy
Executive Director – Communications 
ADAPT Pharma®
thomas.duddy@adaptpharma.com 
484-431-8223

 

1 Cotter, John. Opioid overdoses hitting Alberta First Nations disproportionately hard; report. The Canadian Press. 2017; Available at: https://globalnews.ca/news/3851061/opioid-overdoses-hitting-alberta-first-nations-disproportionately-hard-report/

2 MMIT Formulary Analytics, March 2018

3 IMS Health, NPA Extended Insights Audit, February 2018