FDA Joint Meeting Endorses Commitment to Higher Doses and Broader Access for Naloxone to Help in Fight Against Opioid Overdose
October 6, 2016
Vote follows discussion on the distinction of community needs and access
Dublin, Ireland – October 6, 2016 – Adapt Pharma Limited (Adapt Pharma) participated in yesterday’s joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), to address the need of appropriate dosing for naloxone products used in the community.
At the conclusion of the meeting, the Advisory Committees determined two recommendations related to dosing. First, the Committees recommended that the FDA should increase the minimum acceptable exposure for community use naloxone products from the current level of 0.4mg by injection; and second, that the minimum standards used to support approval of naloxone products should not differ between adults and children.
NARCAN® Nasal Spray is the only FDA-approved, naloxone product intended for community use that currently exceeds the current 0.4mg dosing standard. It is also approved for use in patients ages four weeks and older.
“We fully support the recommendations of the Advisory Committees to the FDA,” said Seamus Mulligan, CEO of Adapt Pharma – manufacturer of the NARCAN® Nasal Spray 4mg product.
The Committees heard testimony from each of the companies currently marketing or investigating naloxone products, as well as comments from drug addiction experts, practicing physicians and caregivers about the importance of improving access to a consistent, reliable dose.
ABOUT NARCAN® (naloxone HCl) 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 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 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 http://www.NARCAN.com/pdf/NARCAN-Prescribing-Information.pdf
AVAILABILITY OF NARCAN® NASAL SPRAY
NARCAN® Nasal Spray is available to individuals in leading retail pharmacies.
Qualifying group purchasers may source NARCAN® Nasal Spray 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 firstname.lastname@example.org.
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: a href=”http://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf” target=”_blank”>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.
For Media Inquiries
Thom Duddy, Adapt Pharma
Executive Director, Communications