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The recommended dose for Namenda is currently 10 mg two times a day (20mg/day), or for patients with severe renal impairment 5 mg twice a day (10mg/day). Patients in this study were titrated to 28 mg/day in a once-dailymodified release formulation. Namenda is currently available in tablets orliquid form.
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"The higher dosage and once-daily formulation will provide patients withthe efficacy and tolerability expected from Namenda, in a more convenientonce-daily form," said Ivan Gergel, M.D., Senior Vice President of ScientificAffairs at Forest Laboratories and President of the Forest Research Institute."Based on the results of this study, Forest plans to pursue a new drugapplication for the memantine extended-release once-daily formulation."
About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatientstaking a cholinesterase inhibitor was conducted in multiple centers inArgentina, Chile, Mexico, and the U.S. Patients in the 24-week study wererandomly assigned to receive either 28 mg/day of memantine extended release orplacebo. The primary endpoints evaluated were change from baseline on theSevere Impairment Battery (SIB) and the Clinician's Interview-Based Impressionof Change Plus Caregiver Input (CIBIC-Plus) rating at week 24. The studyshowed statistically significant higher cognitive abilities, as measured bythe SIB, and clinical global status, as measured by the CIBIC-Plus, inpatients treated with memantine 28 mg extended release compared to thosetreated with placebo (p=0.001 for SIB and p=0.008 for CIBIC-Plus, both usingthe pre-defined last observation carried forward analyses). The study alsoshowed that the once-daily memantine extended-release formulation was welltolerated. The most common adverse events occurring at a higher rate thanplacebo were dizziness, diarrhea and headache.
About Alzheimer's Disease
Alzheimer's disease is a progressive disease of the brain and the mostcommon type of dementia. Dementia is used to describe the progressive loss ofcognitive, intellectual, or functional abilities. Published reports projectthat by 2050 more than 16 million people in the U.S. will have Alzheimer'sdisease. Currently, all Alzheimer's disease medications approved in the U.S.other than Namenda belong to a class of agents called cholinesteraseinhibitors.
About Namenda
Namenda (memantine HCl) is the first in a class of medications with aunique mechanism of action that focuses on the glutamate pathway, a target forthe treatment of Alzheimer's disease. Indicated for the treatment of moderateto severe Alzheimer's disease, the FDA approved Namenda in October 2003 basedon three studies of Namenda used alone as monotherapy or in patients on astable dose of donepezil.
Namenda is contraindicated in patients with known hypersensitivity tomemantine HCl or any excipients used in the formulation. The most commonadverse events reported with Namenda (greater than or equal to 5% and higherthan placebo) in placebo-controll
