Forest Laboratories, Inc. & Pierre Fabre Medicament Announce Positive Phase III Results with Levomilnacipran in Patients with...
July 18 2011 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre
Medicament today announced preliminary top-line results from a
Phase III study of levomilnacipran for the treatment of adults with
major depressive disorder (MDD). Analyses of the data indicate a
statistically significant improvement was achieved for
levomilnacipran treated patients for all dose groups compared to
placebo on the primary efficacy endpoint which was change from
baseline to end of week 8 in the Montgomery-Asberg Depression
Rating Scale-Clinician Rated (MADRS-CR) total score. Further
analyses of the data are ongoing.
“Depressed patients often struggle to find the right
antidepressant and the need for new medications is high. These
positive Phase III results are very encouraging and support the
continued research of levomilnacipran in adult patients with major
depressive disorder,” said Dr. Marco Taglietti, Senior Vice
President, Research & Development and President, Forest
Research Institute.
This study is part of the ongoing development program for
levomilnacipran for the treatment of MDD, which also includes a
Phase III flexible-dose study reported in January 2011. Results
from two additional placebo-controlled Phase III studies are
expected at the end of this year and spring 2012, respectively.
About this Phase III Study
This was a randomized, double-blind, placebo-controlled,
fixed-dose study evaluating the efficacy, safety and tolerability
of levomilnacipran in patients with MDD. Following a 1-week
single-blind, placebo run-in period, 724 men and women, 18 to 65
years of age, who met the Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
criteria for MDD and had a minimum score of 30 on the MADRS-CR,
were randomized to receive levomilnacipran at 40, 80 or 120 mg once
daily, or placebo for 8 weeks. This was followed by an additional
2-week double-blind down-taper period.
The primary analysis was performed using the Mixed-Effects Model
Repeated Measure (MMRM) analysis. The placebo corrected difference
in mean change from baseline to end of week 8 in MADRS-CR total
score was: -3.2 (p=0.019), -4.0 (p=0.004) and -4.9 (p
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