NEW YORK, Aug. 31 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. announced today that in a preliminary analysis, data from the first Phase III study of the investigational Alzheimer's disease treatment, neramexane, failed to achieve statistical significance. The six-month, double-blind, parallel-group Phase III study was designed to evaluate the safety and efficacy of combination therapy with neramexane and any of the three most widely prescribed acetylcholinesterase inhibitors (AChEI) compared to an AChEI alone in 415 outpatients with moderate to severe Alzheimer's disease. Early analysis of data indicates that patients receiving neramexane and an AChEI did not achieve a statistically significant difference compared to patients on an AChEI alone on the study's primary endpoints of cognition and function. The primary endpoints were the Severe Impairment Battery (SIB), a measure of cognition, and the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory, modified for severe dementia (ADCS-ADLsev), a measure of functionality. The secondary endpoint, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), also failed to show statistical significance. There were no safety issues identified in the study. Further analysis of these data will be completed in the coming months.
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Forest is currently enrolling moderate to severe Alzheimer's disease patients in a second Phase II/III study examining neramexane as monotherapy compared to placebo and plans to continue the clinical development of the compound.
Neramexane is a cyclohexane derivative belonging to a class of drugs called N-methyl-D-aspartate (NMDA)-receptor antagonists. Neramexane is believed to selectively block the effects associated with abnormal transmission of glutamate (a neurotransmitter that performs an integral role in the neural pathways associated with learning and memory) while allowing for the physiological transmission associated with normal cell functioning. The abnormal transmission of glutamate and the related excitotoxic processes are believed to play a role in Alzheimer's disease.
Neramexane is being developed jointly by Forest and its licensor, Merz Pharmaceuticals, a German-based specialty pharmaceutical company dedicated to research and development in the fields of neurology and psychiatry.
Alzheimer's is a progressive disease of the brain and it is the most common type of dementia. The term 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 United States will have Alzheimer's disease.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Campral(R) (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation when used in combination with psychosocial support; Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder; Celexa(R) (citalopram HBr), an antidepressant; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(TM) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Aerobid(R) (flunisolide), an inhaled steroid indicated for the treatment of asthma; and Tiazac(R) (diltiazem HCl), a once-daily diltiazem, indicated for the treatment of angina and hypertension.
*Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the period ended June 30, 2004. Actual results may differ materially from those projected.
Forest Laboratories, Inc.