Healthcare Industry News: Azur Pharma
News Release - April 11, 2016
Adapt Pharma Names Mike Kelly President of U.S. OperationsContributing Over 25 Years of Pharmaceutical Expertise to Adapt Executive Team
DUBLIN, April 11, 2016 -- (Healthcare Sales & Marketing Network) -- Adapt Pharma, (www.adaptpharma.com) announced today that Mike Kelly has been appointed as President of U.S. Operations. In this role, Mike will have responsibility for all of the company's U.S. operating activities. He will report to Eunan Maguire, Chief Operating Officer of Adapt Pharma.
Mike brings nearly three decades of pharmaceutical experience, playing an instrumental role in the creation, development and strengthening of specialty brands and businesses for a number of pharmaceutical companies. He joins Adapt Pharma from Covis Pharmaceuticals, Inc., where he served as Chief Executive Officer and Board member. Prior to Covis, Mike was a member of the founding management team of Azur Pharma and later, following a strategic merger, served as Senior Vice President of Sales and Marketing for Jazz Pharmaceuticals PLC. Mike earned his Master of Business Administration from Rider University in Lawrenceville, New Jersey.
"I am delighted to welcome Mike to Adapt Pharma. Mike has established a highly successful track record in leadership roles in specialty pharmaceuticals," said Seamus Mulligan, Chairman and Chief Executive Officer of Adapt Pharma. "His experience will be of great value as Adapt Pharma expands its commercial presence, starting with the launch of NARCANŽ (naloxone HCl) Nasal Spray."
"I am excited to take on this role and look forward to working with our talented senior leadership to grow Adapt Pharma in the U.S.," said Mike. "Most immediately, I am proud to support a product like NARCANŽ Nasal Spray and expand the opportunity to help Americans, impacted by opioid overdose in our country."
For questions regarding NARCANŽ Nasal Spray distribution, please call 1-844-4NARCANŽ (462-7226)
NARCANŽ NASAL SPRAY INDICATION AND IMPORTANT SAFETY INFORMATION
NARCANŽ (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. NARCANŽ Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
NARCANŽ Nasal Spray is not a substitute for emergency medical care.
IMPORTANT SAFETY INFORMATION
NARCANŽ 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.
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.
Source: Adapt Pharma
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