The recently completed North American Phase III clinical trial for Labopharm
Inc’s once-daily formulation of the antidepressant trazodone has
demonstrated significantly improved patient sleep patterns. Labopharm plans
to file a New Drug Application (NDA) for its once-daily formulation of
trazodone with the US Food and Drug Administration later this year.
"The positive results of this study not only demonstrate the efficacy and
safety of our once-daily formulation, but also the ability of our
formulation to significantly improve the overall quality of sleep—there was
significantly less awakening at night," said James R. Howard-Tripp,
president and CEO, Labopharm Inc. "It is recognized that a major challenge
in treating depression is having patients comply with taking their
medication due to slow onset of action and exacerbation of sleep disturbance
and agitation. As a result, a once-daily depression treatment that also
reduces agitation and improves quality of sleep, thus reducing the need for
add-on therapies, should be well positioned in the antidepressant
marketplace. We believe that our once-daily trazodone formulation is such a
treatment."
Trazodone is an atypical antidepressant that helps to treat depression by
improving sleep as a result of sedative effects caused by activation of
histamine receptors and initiation and restoration of deep sleep cycles as a
result of serotonin receptor activation. This may be of clinical benefit in
depressed patients who have agitation, insomnia, or poor sleep quality
associated with their depression.
