Adapt Pharma® Announces Partnership With New York To Provide NARCAN® (naloxone HCl) Nasal Spray 4mg

DUBLIN, Oct. 9, 2017 /PRNewswire/ -- Adapt Pharma, Inc. (www.adaptpharma.com) today announced a partnership with the New York State Department of Health, New York City Health Department, and NYC Health + Hospitals for the distribution of NARCAN® (naloxone HCI) Nasal Spray 4mg to equip law enforcement, first responders, government and community organizations in New York with the highest concentrated dose of intranasal naloxone currently available in a ready-to-use, needle-free, nasal spray. 

Naloxone helps reverse the effects of opioid overdoses and is increasingly being used by first responders and community members in the fight against the opioid epidemic. NARCAN® Nasal Spray 4mg is the only FDA-approved, needle-free formulation of naloxone that does not require assembly or any specialized training. NARCAN® Nasal Spray is not a substitute for emergency medical care, and when used, patients should seek medical care.   

New York State Department of Health Commissioner Dr. Howard Zucker said: "Under Governor Cuomo's leadership, New York State is fighting the opioid epidemic each and every day. By arming those on the front lines with a ready-to-use treatment to help reverse an overdose, we are providing New Yorkers with the ability to potentially save a life. Today's announcement builds upon the Department of Health's ongoing efforts to end the opioid epidemic and I thank Adapt Pharma for their partnership."

This partnership will make NARCAN® Nasal Spray available to over 400 key stakeholder organizations throughout New York City and New York State. Among these stakeholders are first responders, law enforcement, and registered opioid overdose prevention programs.   

"A key goal of HealingNYC, our effort to address the opioid crisis, is to put naloxone in the hands of everyday New Yorkers who may witness an overdose," said Health Commissioner Dr. Mary T. Bassett. "This partnership will greatly enhance our efforts by placing ready-to-use NARCAN®-brand naloxone in the hands of non-medically trained New Yorkers."

"Every second counts when it comes to responding to an opioid emergency," said Mike Kelly, President, U.S. Operations, Adapt Pharma. "NARCAN® Nasal Spray was designed to be utilized by the people in the community that are not medically-trained."   

Additional doses may be necessary until emergency medical assistance arrives. Adapt Pharma always recommends that individuals review and have a complete understanding of the Patient Information and the Instructions for Use for NARCAN® Nasal Spray.

"NYC Health + Hospitals is proud to be a part of the efforts to increase the availability of highly concentrated 4mg NARCAN® Nasal Spray for those at risk of an opioid overdose," said Luke Bergmann, PhD, assistant vice president, Office of Behavioral Health, NYC Health + Hospitals. "With a drug crisis driven in part by powerful synthetic opioids, this partnership will give New Yorkers broader access to this potentially life-saving medication."

Greater availability of NARCAN® will allow first responders and citizens to act fast and respond to an opioid emergency. This partnership is the largest in the nation showcasing the impact naloxone intervention can have on communities hit hardest by the opioid crisis. Adapt Pharma commends New York State and New York City for championing this partnership, and is proud to work alongside the Departments of Health in helping to ensure naloxone access and strengthening their efforts to combat the opioid crisis.

NARCAN® NASAL SPRAY
NARCAN® Nasal Spray is the first and only FDA-approved naloxone in a nasal spray for the emergency treatment of a known or suspect opioid overdose. It is available as a ready-to-use, needle-free, 4 mg dose of naloxone in a single spray. 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. 

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, 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 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.

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.

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

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