Forest Laboratories, Inc. to Continue Clinical Development of Neramexane Based on New Clinical Trial Results
July 14 2005 - 2:38PM
PR Newswire (US)
Forest Laboratories, Inc. to Continue Clinical Development of
Neramexane Based on New Clinical Trial Results NEW YORK, July 14
/PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX)
announced today that a recently completed placebo-controlled proof
of concept study of neramexane in the treatment of moderate to
severe Alzheimer's disease showed sufficient clinical activity,
safety, and tolerability to continue development of the compound.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
"We are pleased with the results of this study," said Ivan Gergel,
M.D., Senior Vice President -- Scientific Affairs and President of
the Forest Research Institute. "Even though recruitment of patients
into this study was stopped early due to slow patient enrollment,
the neramexane treatment group actually achieved statistical
significance on scales assessing activities of daily living and
exhibited strong trends in favor of neramexane on measures of
cognition." The 24-week trial was a double-blind, randomized,
placebo-controlled trial conducted at 47 U.S. study sites,
evaluating 198 patients out of an originally planned 400 patients
who were suffering from moderate-to-severe Alzheimer's disease and
who were not receiving any other treatments for their dementia. The
primary outcome assessments were the Alzheimer's Disease
Cooperative Study Inventory -- Activities of Daily Living
(ADCS-ADL19) scale, a measure of daily function, and the Severe
Impairment Battery (SIB), a measure of cognition. At endpoint,
patients on neramexane showed statistically significant improvement
versus placebo-treated patients on the ADCS-ADL19 (p
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