CHICAGO, July 30 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. presented today positive Phase III data of a once-daily extended-release formulation of Namenda(R) (memantine HCl) at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD). The study evaluated the efficacy, safety and tolerability of an innovative, proprietary, 28 mg once-daily extended-release formulation of Namenda compared to placebo in outpatients with moderate to severe Alzheimer’s disease already being treated with a cholinesterase inhibitor (donepezil, galantamine or rivastigmine).
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In the study, patients treated with once-daily extended-release Namenda experienced significant improvements in cognitive performance and global clinical status compared to those receiving placebo. Patients treated with once-daily extended-release Namenda also experienced significant improvements in verbal fluency and behavioral symptoms as compared to placebo. The results build on preliminary findings announced by Forest in February.
“While there is no cure or existing treatment to prevent Alzheimer’s disease, there are currently-available FDA-approved treatments, such as combination therapy with memantine and a cholinesterase inhibitor, which can alleviate symptoms by providing cognitive, functional, and behavioral benefits,” said George Grossberg, MD, Director of Geriatric Psychiatry at Saint Louis University School of Medicine, and the lead investigator who presented the data. “These findings reinforce the safety, tolerability and efficacy of memantine in a newly-developed once-a-day formulation.”
Marco Taglietti, MD, Executive Vice President and Chief Medical Officer at Forest added, “With this novel formulation, the efficacy and tolerability of Namenda is delivered in a more convenient, once-daily dose.”
About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor was conducted in multiple centers in the United States, Argentina, Chile, and Mexico. Patients in the 24-week study were randomly assigned to receive either 28 mg/day of memantine once-daily 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 significantly 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 once-daily extended-release compared to placebo (p=0.001 for SIB and p=0.008 for CIBIC-Plus, both using pre-defined last observation carried forward analyses). The CIBIC-Plus is a global measure of a patient’s overall status evaluating cognition, behavior, and activities of daily living.
Results for a secondary endpoint and additional assessment variables reinforced the positive findings seen with the primary endpoints. Assessments were conducted to evaluate change in behavior from baseline using the Neuropsychiatric Inventory (NPI) at 24 weeks and change in verbal fluency from baseline using the Verbal (Semantic) Fluency Test at 24 weeks. Memantine provided significant benefits over placebo (p=0.005 for NPI and p=0.004 for verbal fluency). Measurement of daily living activities using the 19-item AD Cooperative Study-Activities of Daily Living scale (ADCS-ADL) demonstrated maintenance of function during the study period, but this was not significantly different from placebo (p=0.18).
The study also demonstrated that once-daily extended-release memantine was well tolerated. The treatment-emergent AEs (TEAEs) profile was similar between the groups; no TEAEs were experienced by greater than or equal to 5% of memantine patients, and at an incidence at least twice that of the placebo group. The most common adverse events occurring at a higher rate than placebo were dizziness (4.7% vs 1.5%), diarrhea (5.0% vs 3.9%), and headache (5.6% vs 5.1%).
About Alzheimer’s Disease
Alzheimer’s disease is a progressive, degenerative 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. By 2050, the number of individuals age 65 and over with Alzheimer’s disease could range from 11 million to 16 million. Currently, all Alzheimer’s disease medications approved in the US other than Namenda belong to a class of agents called cholinesterase inhibitors.
About Namenda
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 or in combination with another Alzheimer’s disease drug. At present, the recommended dose of Namenda is 10 mg two times a day (20 mg/day).
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 vs placebo (greater than or equal to 5% and higher than placebo) were dizziness, confusion, headache, and constipation. In patients with severe renal impairment, dosage should be reduced.
About Forest Laboratories
Forest Laboratories is a US-based pharmaceutical company with a long track record of building partnerships and developing and delivering products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
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 Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
CONTACT: Frank Perier, Jr., Senior Vice President - Finance and Chief
Financial Officer, Forest Laboratories, Inc., +1-212-224-6611,
Frank.Perier@frx.com; or Cassie Ercanbrack, Fleishman-Hillard,
+1-212-453-2391, Cassie.Ercanbrack@fleishman.com
Web site: http://www.frx.com/
