Forest Laboratories, Inc. Announces Positive Results of Memantine Study of Once-Daily Formulation
NEW YORK, February 05, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. today announced preliminary results of a Phase III study of memantine HCl (currently marketed as Namenda(R), a twice-daily immediate- release formulation) in a novel once-daily formulation. The study evaluated the efficacy, safety, and tolerability of an innovative, proprietary, 28 mg memantine extended-release, once-daily formulation compared to placebo in outpatients with moderate to severe Alzheimer's disease currently treated with a cholinesterase inhibitor. The results indicate that patients treated with memantine 28 mg extended-release formulation experienced statistically significant benefits in cognition and clinical global status compared to placebo. Additional data from the study are expected to be presented later in the year.
The recommended dose for Namenda is currently 10 mg two times a day (20 mg/day), or for patients with severe renal impairment 5 mg twice a day (10 mg/day). Patients in this study were titrated to 28 mg/day in a once-daily modified release formulation. Namenda is currently available in tablets or liquid form.
"The higher dosage and once-daily formulation will provide patients with the efficacy and tolerability expected from Namenda, in a more convenient once-daily form," said Ivan Gergel, M.D., Senior Vice President of Scientific Affairs at Forest Laboratories and President of the Forest Research Institute. "Based on the results of this study, Forest plans to pursue a new drug application for the memantine extended-release once-daily formulation."
About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatients taking a cholinesterase inhibitor was conducted in multiple centers in Argentina, Chile, Mexico, and the U.S. Patients in the 24-week study were randomly assigned to receive either 28 mg/day of memantine extended release or placebo. The primary endpoints evaluated were change from baseline on the Severe Impairment Battery (SIB) and the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) rating at week 24. The study showed statistically significant higher cognitive abilities, as measured by the SIB, and clinical global status, as measured by the CIBIC-Plus, in patients treated with memantine 28 mg extended release compared to those treated with placebo (p=0.001 for SIB and p=0.008 for CIBIC-Plus, both using the pre-defined last observation carried forward analyses). The study also showed that the once-daily memantine extended-release formulation was well tolerated. The most common adverse events occurring at a higher rate than placebo were dizziness, diarrhea and headache.
About Alzheimer's Disease
Alzheimer's disease is a progressive disease of the brain and the most common type of dementia. Dementia is used to describe the progressive loss of cognitive, intellectual, or functional abilities. Published reports project that by 2050 more than 16 million people in the U.S. will have Alzheimer's disease. Currently, all Alzheimer's disease medications approved in the U.S. other than Namenda belong to a class of agents called cholinesterase inhibitors.
Namenda (memantine HCl) is the first in a class of medications with a unique mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe Alzheimer's disease, the FDA approved Namenda in October 2003 based on three studies of Namenda used alone as monotherapy or in patients on a stable dose of donepezil.
Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or any excipients used in the formulation. The most common adverse events reported with Namenda (greater than or equal to 5% and higher than placebo) in placebo-controlled trials in patients with Alzheimer's disease were dizziness, confusion, headache, and constipation. In patients with severe renal impairment, dosage should be reduced.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a U.S.-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation; and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking agent indicated for the treatment of hypertension. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker; Benicar HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product; and AZOR(TM)* (amlodipine and olmesartan medoxomil), a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.
Forest Laboratories markets Namenda(R) (memantine HCl) in the United States under license from Merz Pharma GmbH & Co. KGaA of Germany.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in each of Forest Laboratories' and Mylan's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Posted: February 2008