Forest Announces That Neramexane Did Not Demonstrate Statistical Significance in Recently Completed Phase III Trial in Patients
August 31 2004 - 5:11PM
PR Newswire (US)
Forest Announces That Neramexane Did Not Demonstrate Statistical
Significance in Recently Completed Phase III Trial in Patients with
Moderate to Severe Alzheimer's Disease NEW YORK, Aug. 31
/PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) 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. About Neramexane 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 Disease 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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, Web site: http://www.frx.com/
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