DUBLIN, Feb. 22, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, is proud to be a Gold sponsor of the Alzheimer's Foundation of America's (AFA) "15th Anniversary National Educating America Tour." This tour commemorates AFA's15 years of educating individuals about Alzheimer's and the availability of services and programs. The tour will include AFA's free Concepts in Care Educational Conferences, free memory screenings and displays of the AFA Quilt to Remember.
The educational conferences will provide individuals throughout the nation the opportunity to learn from leading dementia and caregiver experts about topics including access to healthcare, transitioning from home to residential care setting, safeguarding the home, long-term care, perceptions of aging, and clinical trials and research.
"We are excited to be a Gold sponsor of the 15th Anniversary Educating America Tour," said Will Kane, senior vice president marketing, U.S. General Medicine at Allergan. "As a leader in this space, Allergan is committed to the development of treatments for Alzheimer's Disease and to education about the disease, which is why this partnership is so important to us."
The tour kicks off February 22, in San Francisco, Calif. and continues through late October 2017 visiting Las Vegas, Nev.; West Palm Beach, Fla.; Birmingham, Ala.; New York, N.Y.; Philadelphia, Pa.; Franklin, Tenn.; Durham, N.C.; Washington, D.C.; Melville, N.Y.; Chicago, Ill.; and Boston, Mass.
"Our organization was founded by a caregiver to be the resource his family did not have when dementia entered their lives," said Charles J. Fuschillo, Jr., AFA's president and chief executive officer. "With this tour, we hope to educate thousands of people across the country, and it is only with the help of generous sponsors like Allergan that we are able to do that."
Currently, more than 5 million Americans are living with Alzheimer's disease and that number is expected to nearly triple by the year 2050. It is estimated that more than 15 million people have provided informal care (care provided by friends and family) to people living with Alzheimer's Disease.
Allergan is the manufacturer of NAMZARIC® (memantine and donepezil hydrochlorides) extended-release capsules, for patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg).
For more information about NAMZARIC, visit www.Namzaric.com.
NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil HCl once daily
Memantine hydrochloride extended-release is the active ingredient in the currently marketed NAMENDA XR®, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in ARICEPT® (donepezil hydrochloride), which is indicated for the treatment of mild to severe dementia of the Alzheimer's type. Allergan and Adamas collaborated on the development of the fixed-dose combination and Allergan owns the exclusive U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside of the U.S.
IMPORTANT SAFETY INFORMATION
NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
WARNINGS AND PRECAUTIONS
NAMZARIC is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
NAMZARIC may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block. Bradycardia or heart block may manifest in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil hydrochloride, an active ingredient in NAMZARIC.
Peptic Ulcer Disease and Gastrointestinal Bleeding
Patients treated with NAMZARIC should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, those with a history of ulcer disease, or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
Nausea and Vomiting
NAMZARIC can cause diarrhea, nausea, and vomiting. Although in most cases, these effects have been mild and transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride, patients should be observed closely at the initiation of treatment.
NAMZARIC may cause bladder outflow obstructions. Conditions that raise urine pH may decrease the urinary elimination of memantine, an active ingredient in NAMZARIC, resulting in increased plasma levels of memantine.
Cholinomimetics, including donepezil hydrochloride, are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer's disease.
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
- The most common adverse reactions, occurring at a frequency of at least 5% in patients taking memantine hydrochloride extended-release 28 mg/day, and greater than placebo, were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
- The most common adverse reactions, occurring at a frequency of at least 5% in patients taking donepezil, and at twice or more the rate of placebo, were diarrhea (10% vs 4%), anorexia (8% vs 4%), vomiting (8% vs 4%), nausea (6% vs 2%), and ecchymosis (5% vs 2%).
- Alterations of urine pH toward the alkaline condition may lead to an accumulation of memantine with a possible increase in adverse reactions. NAMZARIC should be used with caution under conditions that may be associated with increased urine pH including alterations by diet, drugs, and the clinical state of the patient.
- The combined use of memantine hydrochloride with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
- Inhibitors of CYP450, 3A4 (eg, ketoconazole) and 2D6 (eg, quinidine), inhibit donepezil metabolism in vitro. Whether there is a clinical effect of quinidine is not known.
- Inducers of CYP3A4 (eg, phenytoin, carbamazepine, dexamethasone, rifampin, and phenobarbital) could increase the rate of elimination of donepezil.
- Cholinesterase inhibitors, including donepezil hydrochloride, have the potential to interfere with the activity of anticholinergic medications.
- A synergistic effect may be expected when cholinesterase inhibitors, including donepezil hydrochloride, are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
About Alzheimer's Foundation of America (AFA)
The Alzheimer's Foundation of America, based in New York, is a non-profit organization that unites more than 2,600 member organizations nationwide in the goal of providing optimal care and services to individuals living with dementia, and to their caregivers and families. Its services include a national, toll-free helpline (866-232-8484) staffed by licensed social workers, educational conferences and materials, a free quarterly magazine for caregivers, the National Memory Screening Program, and "AFA Partners in Care" dementia care training for healthcare professionals.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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