Adapt Pharma Marks One-Year Anniversary of NARCAN® Nasal Spray (naloxone HCl) 4mg Launch in the United States

"Most opioid overdose deaths happen in non-medical settings like homes and an increasing proportion involve synthetic opioids, such as fentanyl, making the availability of community-ready naloxone products more important than ever," said Seamus Mulligan, Chief Executive Officer of Adapt Pharma.  "Our mission is to expand access to NARCAN® Nasal Spray by ensuring affordability and removing barriers for both first responders as well as providers and patients."

Narcan is not a substitute for emergency medical care, and repeated doses may be necessary. Patients may experience acute opiate withdrawal symptoms and should be kept under surveillance. Please see Indications and Important Safety Information below in the use of Narcan. 

Adapt Pharma has worked throughout the past year to improve affordable access to NARCAN® Nasal Spray by:

• Offering a stable discounted price and free NARCAN® to those serving the public – Local and state government agencies, harm reduction groups, emergency responders, and other nonprofits continue to be able to purchase NARCAN® Nasal Spray at the discounted Public Interest Price of $75 per two-dose pack ($37.50 per dose). The price has not been increased since launch. Adapt Pharma also launched an experience program, in which thousands of doses of NARCAN® Nasal Spray were donated to public entities in areas of the country most in need.
• Partnering with pharmacies – Since many states and retail pharmacies allow residents to purchase NARCAN® Nasal Spray directly from a pharmacist without an individualized prescription, Adapt Pharma has worked with multiple, national retailers, like CVS, Rite-Aid, Albertson's and Walgreens, to improve in-store availability and awareness.  Additionally, for those paying cash, Adapt Pharma has partnered with retail pharmacies to reduce out-of-pocket costs.
• Contracting broad coverage through insurance – 94 percent of insured lives in the United States have coverage for NARCAN® Nasal Spray ^[1]. According to IMS Health, nearly three quarters (74 percent) of prescriptions for NARCAN® Nasal Spray now have a co-pay of $10 or less ^[2]. 
• Donating free NARCAN® Nasal Spray to U.S. high schools – Adapt Pharma's collaboration continues with the National Association of School Nurses (NASN) to expand their educational efforts to increase awareness of opioid-related risks among students, educators, families and communities.  Through the Free NARCAN® Nasal Spray High School Program, Adapt Pharma has supplied free of charge more than 3,000 doses of NARCAN® Nasal Spray to high schools in 32 states. Statewide programs in Pennsylvania and Kentucky are leading the way in promoting opioid abuse education and prevention, a crucial step in preventing even more opioid-related deaths this year.
• Raising awareness of naloxone in today's opioid epidemic – Adapt Pharma continues to increase awareness of today's opioid epidemic through a series of testimonials and educational videos that have been distributed online and through social media.

"In its first year of availability, NARCAN® Nasal Spray filled the need of thousands of Americans who were faced with reversing an opioid-related overdose," said Mike Kelly, President of U.S. Operations for Adapt Pharma.  "In year two, we plan to continue expanding affordable access to NARCAN® Nasal Spray, supporting guidelines focused on prescribing naloxone to persons at high risk of overdose while taking opioid medications. 

NARCAN® Nasal Spray is the only FDA-approved naloxone in a nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray provides a ready-to-use, needle-free alternative to currently available opioid overdose emergency treatments. NARCAN® Nasal Spray is not a substitute for emergency medical care, and repeat applications may be necessary.  Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance. Please see Indications and Important Safety Information below. 

[1] MMIT Formulary Analytics November 2016.

[2] IMS Health, NPA Extended Insights Audit, September 2016

Please see full prescribing information for NARCAN^® Nasal Spray, available at http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf

AVAILABILITY OF NARCAN^® NASAL SPRAY
NARCAN^® Nasal Spray 4mg was launched in February of 2016 and is widely available. NARCAN^® Nasal Spray 2mg has been approved by the Food and Drug Administration (FDA) on Jan. 25, 2017 and Adapt will provide further information on its commercial availably when details are confirmed.

Qualifying group purchasers may source NARCAN^® Nasal Spray 4mg directly from wholesalers and distributors. To place a pre-order immediately or for assistance in sourcing NARCAN^® Nasal Spray please contact Adapt Pharma's dedicated Customer Service Team at 844-4-NARCAN^® (844-462-7226) or email [email protected].

NARCAN^® NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION
Indications – 4mg

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. 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, goose bumps (piloerection), yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure and increased heart rate (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 be characterized by 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.

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.

See Instructions for Use and full prescribing information in the use of this product, available here: http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf.

Additional information, including full prescribing information for NARCAN^® Nasal Spray, and important safety information and instructions for use, is also available at www.NARCAN.com.

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.

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NARCAN^® NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION
Indications – 2mg

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.

Limitations of Use:
Restrict prescription of NARCAN Nasal Spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

Important Safety Information
NARCAN^® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride. 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, goose bumps (piloerection), yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure and increased heart rate (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 be characterized by convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

There are limited data to inform if the 2 mg dose of NARCAN Nasal Spray will avoid precipitation of severe opioid withdrawal in the setting of opioid dependence.  However, the 2 mg dose may not provide an adequate and timely reversal in persons who may be exposed to an overdose of a potent or very high dose of opioids.

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.

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.

See Instructions for Use and full prescribing information in the use of this product, available here: http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf.

Additional information, including full prescribing information for NARCAN^® Nasal Spray, and important safety information and instructions for use, is also available at www.NARCAN.com.

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.

ABOUT ADAPT PHARMA
Adapt Pharma is a privately-held pharmaceutical company committed to positively impacting the lives of patients. Adapt Pharma's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development, and FDA approved, pharmaceutical products. Adapt Pharma's company headquarters is in Dublin, Ireland and its U.S. headquarters is in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.

SOURCE Adapt Pharma