Survey Data Published on Community Use of NARCAN® (naloxone HCI) Nasal Spray 4 mg to Help Reverse Opioid-Related Overdose - Current Medical Research and Opinion Journal
June 6, 2017
Dublin, Ireland – June 6, 2017 – Adapt Pharma (www.AdaptPharma.com) announces recent publication of survey data analyzing community use of NARCAN® Nasal Spray 4 mg. The manuscript, Use of Naloxone Nasal Spray in the Community Setting: a Survey of Use by Community Organizations, was published in the medical journal, Current Medical Research and Opinion. The publication reviews results of a survey of the real-world experiences and outcomes of eight police and community organizations using the FDA-approved NARCAN® Nasal Spray 4 mg in community settings.
Researchers examined the outcomes of attempted opioid-related overdose reversals reported by first responders and community health organizations where NARCAN® Nasal Spray 4 mg was administered. Participating organizations provided data on several outcome measures including reversal outcomes, agents involved in suspected overdoses and observed events.
“This survey emphasizes the role community-use naloxone can play and cements naloxone as an integral part of the opioid epidemic response,” said George K. Avetian, DO, primary investigator of the survey. “It is important that we understand how ready-to-use naloxone is used in the community setting, so that we may apply those learnings to other scenarios and emergency preparedness strategies.”
“First responders and harm reduction advocates play a vital role in addressing the opioid overdose epidemic impacting our communities,” said Mike Kelly, President, U.S. Operations, Adapt Pharma, Inc. the makers of NARCAN® Nasal Spray. “Anyone using prescribed or illicit opioids can potentially be at risk of experiencing an opioid overdose emergency. When responding to such an emergency, ready-to-use and layperson-designed naloxone formulations, such as NARCAN® Nasal Spray, allow family and friends to rapidly respond to an opioid overdose emergency in the community setting while waiting for emergency medical help to arrive.”
Survey data were generally collected via case report forms, data tables and qualitative email summaries of the participating first responders and community health organization representatives. Real-world data evaluations are limited due to the retrospective nature of the data and potential biases. The survey, conducted in August 2016, was designed and implemented by Synchrony Medical Communications, LLC and sponsored by Adapt Pharma, Inc.
NARCAN® Nasal Spray is the first and only FDA-approved naloxone in a nasal spray for the emergency treatment of opioid overdose. It is now 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. Please see Indications and Important Safety Information below.
About NARCAN® (naloxone HCI) NASAL SPRAY
NARCAN® Nasal Spray is 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. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of NARCAN® nasal spray.
If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of NARCAN® Nasal Spray in an alternate nostril using a new NARCAN® Nasal Spray. If the patient responds to NARCAN® Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose and continue surveillance of the patient. If there is still no response and additional doses are available, administer additional doses of NARCAN® Nasal Spray every 2 to 3 minutes using a new NARCAN® Nasal Spray in alternate nostrils with each dose until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
Please see Indications and Important Safety Information below.
Please see full prescribing information for NARCAN® Nasal Spray, available at https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf
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 survey: 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: 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.
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.
ADAPT PHARMA MEDIA CONTACT INFORMATION
Executive Director – Communications