Additions to Support Growth in NARCAN® (naloxone HCI) Nasal Spray Distribution and Advance R&D Pipeline of Five Addiction Focused Programs
DUBLIN, March 5, 2018 /CNW/ -- Adapt Pharma® (www.adaptpharma.com) announced today Phil Shanahan, PhD will be joining as Vice President of Technical Operations and Ryan Loughlin, PhD has joined as Director of Drug Development. Both will report to Fintan Keegan, who was recently promoted to Chief Technical Officer.
These appointments will add significant experience to the existing technical and development team, allowing Adapt Pharma to advance the company's addiction-focused research and development pipeline while continuing to support the growing distribution of NARCAN® (naloxone HCI) Nasal Spray 4 mg.
Phil was most recently Vice President, Quality Operations at Alkermes, plc. and brings more than three decades of technical and quality experience from a range of pharmaceutical companies, including Elan Corporation, Servier and Janssen. He obtained his doctorate in analytical biotechnology and his Bachelor of Science in chemistry from University College Cork, Ireland.
Ryan joins Adapt Pharma from Teva Pharmaceuticals where he most recently served as Director of Formulation Development. He obtained a Master of Pharmacy and a PhD in Pharmaceutics from Queen's University Belfast, Northern Ireland.
"I am delighted to welcome Phil and Ryan to Adapt Pharma where we successfully developed and launched NARCAN® Nasal Spray 4 mg – the leading community-use naloxone in North America. Phil and Ryan are central to our goals of progressing the development of new treatment options to support important public heath requirements in the area of addiction treatment while supporting the growth of NARCAN® Nasal Spray distribution," said Seamus Mulligan, Chairman and Chief Executive Officer of Adapt Pharma. "Our pipeline now comprises four programs targeting the emergency treatment of opioid overdose with expected regulatory submissions ranging from 2018 to 2020 and our pre-clinical opioid dependency treatment program."
NARCAN® Nasal Spray 4mg is the first and only FDA-approved, needle-free formulation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training and is also the highest concentrated dose of intranasal naloxone currently available. NARCAN® Nasal Spray is not a substitute for emergency medical care, and additional doses of NARCAN® Nasal Spray may be required until emergency medical assistance arrives. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.
Please see Indications and Important Safety Information below.
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® (naloxone HCI) 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.
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.
For questions regarding NARCAN® Nasal Spray distribution, please call 1-844-4NARCAN® (462-7226).
ABOUT ADAPT PHARMA®
Adapt Pharma® is a privately-held company committed to expanding affordable access to Narcan® (naloxone HCI) Nasal Spray and to progressing treatment options in the field of addiction. Adapt Pharma's company headquarters is in Dublin, Ireland with U.S. headquarters in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.
SOURCE Adapt Pharma
Thom Duddy, Executive Director - Communications, Adapt Pharma®, [email protected], 484-431-8223
Share this article