Adapt Pharma, Limited, launched of a new smartphone app, NARCAN Now. This free app provides guidance and education for recognizing symptoms of a suspected opioid overdose, a 3-step guide for administering NARCAN (naloxone HCI) Nasal Spray, an instructional video and immediate access to local emergency 911 services. The app's simple and easy-to-use design equips those administering NARCAN Nasal Spray with an important new tool that complements the prescribing and patient information. NARCAN Nasal Spray is not a substitute for emergency medical care. See indications and important safety information below.
NARCAN Nasal Spray is the only FDA-approved, ready-to-use naloxone nasal spray that delivers a 4 mg concentrated dose of naloxone in a single spray. NARCAN Nasal Spray is available at a discounted Public Interest Price to qualifying group purchasers including law enforcement, community naloxone distribution programs and first responders. The product has 3rd party insurance coverage. A free carton of NARCAN Nasal Spray is also available for every high school in the United States.
To learn more, please visit narcannasalspray.comor call 1-844-4NARCAN (462-7226).
NARCAN Now launches at a time when opioid overdose deaths have grown to an all-time high and more potent opioids, such as fentanyl, are implicated in a growing proportion of these deaths. NARCAN Nasal Spray, which can be used by laypersons in non-healthcare settings, expands treatment options, because the majority of opioid overdoses are witnessed in the community.
Seamus Mulligan, CEO of Adapt Pharma, commented "Most opioid overdose deaths happen at home and so expanding access to additional formulations of naloxone that can be administered by lay persons at the site of an overdose is a critical step. This app complements NARCAN Nasal Spray by providing rapid access to help a witness recognize a potential opioid overdose and administer NARCAN Nasal Spray."
NARCAN NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION
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, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. 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, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.
See Instructions for Use and full prescribing information in the use of this product, available here: http://www.narcannasalspray.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.NARCANNasalSpray.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.