Allergan to Highlight Data from Its Alzheimer's Disease Portfolio at the 2015 Alzheimer's Association International Conference (AAIC)
DUBLIN, July 20, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that five poster presentations will be given at the 2015 Alzheimer's Association International Conference in Washington DC, July 17 through July 23. Highlights include analyses on the use of memantine, extended-release memantine, and combination therapy with memantine and donepezil. The following data will be presented at this year's meeting:
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Complementary Benefit of Memantine and Donepezil on Activities of Daily Living by Disease Stage When Used Together: Post Hoc Analysis of Two Trials in Moderate to Severe Alzheimer's Disease (Poster #2710) on Tuesday, July 21, 2015, 9:30 a.m. – 4:15 p.m., presented by Suzanne Hendrix, Ph.D., Pentara Corporation, Salt Lake City, UT
Caregiver Distress Related to Neuropsychiatric Symptoms is Reduced with Extended-Release Memantine – Cholinesterase Inhibitor Combination in Patients with Moderate to Severe Alzheimer's Disease (Poster #4636) on Tuesday, July 21, 2015, 9:30 a.m. – 4:15 p.m., presented by Alireza Atri, M.D., Ph.D., Ray Dolby Brain Health Center, California Pacific Medical Center, San Francisco, CA; Massachusetts General Hospital and Harvard Medical School, Boston, MA
A Time-to-Event Analysis of the Efficacy of Memantine in a Pooled Population of Moderate to Severe Alzheimer's Disease Patients (Poster #6086) on Wednesday, July 22, 2015, 9:30 a.m. – 4:15 p.m., presented by Suzanne Hendrix, Ph.D., Pentara Corporation, Salt Lake City, UT
Characteristics of Alzheimer's Disease Patients Switching from Memantine HCl Immediate-Release Tablets to Memantine HCl Extended-Release Tables: A Retrospective Analysis of Administrative Claims (Poster #6102) on Wednesday, July 22, 2015, 9:30 a.m. – 4:15 p.m., presented by Abhilasha Ramasamy, B.Pharm, M.Sc, M.S., Allergan plc, Jersey City, NJ
Impact on Outcomes of Adding Memantine to Donepezil Among Patients with Alzheimer's Disease (Poster #6101) on Wednesday, July 22, 2015, 9:30 a.m. – 4:15 p.m., presented by Abhilasha Ramasamy, B.Pharm, M.Sc, M.S., Allergan plc, Jersey City, NJ
About NAMENDA XR®
NAMENDA XR (memantine HCl) extended release capsules are a higher dose, once-daily formulation of NAMENDA immediate release indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Its mechanism of action focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. The efficacy and safety of NAMENDA XR was established in a 24 week, randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl).
NAMENDA XR 28 mg plus an AChEI demonstrated statistically significant improvement in cognition and global function compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery Scale (2.6 unit mean difference). Global function was measured by the Clinician's Interview-Based Impression of Change Scale (0.3. unit mean difference).
There is no evidence that NAMENDA XR or an AChEI prevents or slows the underlying disease process in patients with Alzheimer's disease.
IMPORTANT SAFETY INFORMATION
Contraindications
- NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.
Warnings and Precautions
- NAMENDA XR should be used with caution under conditions that raise urine pH (including alterations by diet, drugs, and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels and a possible increase in adverse effects.
Adverse Reactions
- The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
- NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.
Drug Interactions
- No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Dosing and Administration
- The recommended starting dose of NAMENDA XR is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
- It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 28 mg once-daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.
- It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 14 mg once-daily capsules the day following the last dose of a 5 mg NAMENDA tablet.
Special Populations
- NAMENDA XR should be administered with caution to patients with severe hepatic impairment.
- A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5-29 mL/min, based on the Cockcroft-Gault equation).
Please visit www.NamendaXR.com for more information and full prescribing information.
About Alzheimer's
Alzheimer's disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behavior that eventually become severe enough to affect daily tasks. An estimated 5.2 million people in the United States are currently living with Alzheimer's disease. Alzheimer's disease is the fifth leading cause of death in the United States among those aged 65 and older and was reported as an underlying cause of death for more than 83,000 Americans in 2010.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
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.
For more information, visit Allergan's website at www.allergan.com.
Forward-Looking Statement
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; risks associated with acquisitions, mergers and joint ventures; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
SOURCE Allergan plc
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