Adapt Pharma to offer all U.S. high schools a free NARCAN® Nasal Spray and fund school-based opioid overdose education

January 25, 2016

Dublin, Ireland – January 25, 2016Adapt Pharma, Limited (“Adapt Pharma”) today announced two national programs at the Clinton Health Matters Initiative Activation Summit to assist in efforts to address the growing risk of opioid overdose among American high-school students. First, Adapt Pharma will offer a free carton of NARCAN® (naloxone hydrochloride) Nasal Spray to all high schools in the United States through the state departments of education. This program will collaborate with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, as part of its work to scale naloxone access efforts nationally.

In addition, Adapt Pharma has provided a grant to the National Association of School Nurses (NASN) to support their educational efforts concerning opioid overdose education materials. To learn more click here or call 844-4-NARCAN.

NARCAN Nasal Spray is the only FDA approved, ready-to-use, needle-free nasal spray version of naloxone hydrochloride, indicated for the emergency treatment of opioid overdose. It is not a substitute for emergency medical care. See below for indication and important safety information. For multimedia content, please visithttp://inr.synapticdigital.com/adaptpharma/NARCAN/.

“We understand the crucial role schools can play to change the course of the opioid overdose epidemic by working with students and families. We also want every high school in the country to be prepared for an opioid emergency by having access to a carton of NARCAN Nasal Spray at no cost,” said Seamus Mulligan, Chairman and CEO of Adapt Pharma. “We look forward to working with our partners to implement these initiatives which build on the significant progress being made by legislators and community groups.”

“We are pleased to encourage public-private collaborations expanding access to naloxone,” said Rain Henderson, CEO of the Clinton Health Matters Initiative. “We are hopeful this effort will facilitate a dialogue amongst students, educators, health professionals, and families about the risks of opioid overdose and ensure naloxone is available in schools that decide to take steps to address opioid overdose emergencies.”

NASN President Beth Mattey noted that school nurses act as first responders in the school setting. “We educate our students, families, and school staff about prescription drug and substance abuse, and help families seek appropriate treatment and recovery options,” Mattey said. “Having access to naloxone can save lives and is often the first step toward recovery. We are taking a proactive approach to address the possibility of a drug overdose in school.”

Both programs build on Adapt Pharma’s recently announced initiative to facilitate affordable access to NARCAN Nasal Spray. Earlier this month, Adapt Pharma, in partnership with the National Association of Counties, National Governors Association, National League of Cities and United States Conference of Mayors, announced it will offer NARCAN Nasal Spray at a discounted Public Interest Price through the U.S. Communities Purchasing Alliance and Premier, Inc. to over 62,000 state and local government agencies. Click here for further details.

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.

 

Important Safety Information

NARCAN® 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.

See Instructions for Use and full prescribing information in the use of this product, available here: https://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.