Sepracor Inc. (Nasdaq: SEPR) today announced that it has completed the
analysis and validation of the preliminary results of a Phase II,
514-patient study evaluating the efficacy and safety of SEP-225289 for
the treatment of Major Depressive Disorder, including patients with
melancholic and atypical features. Sepracor determined that SEP-225289
did not meet the primary efficacy endpoint, which was a reduction in
symptoms of depression following eight weeks of treatment, as assessed
using the clinician-rated, 17-item HAM-D scale (Hamilton Depression
Rating Scale, a standard scale used to assess depression in clinical
trials and consisting of a list of symptoms commonly associated with
depression). The positive control in the study (venlafaxine
extended-release) did achieve separation from placebo that was
statistically significant on the primary endpoint.
In this study, the measured serum concentrations of SEP-225289 were
found to be below expected levels of exposure for both doses studied and
were well below exposure profiles observed in several Phase I studies.
Further, the adverse event profile demonstrated by SEP-225289 was
inconsistent with prior clinical experience and was similar to the side
effect profile observed when patients were administered placebo. As
such, preliminary data are inconclusive pending further investigation of
the dose exposure relationship of SEP-225289.
“While we are clearly disappointed with the findings from the analysis
of the preliminary study results, we are in the process of further
analysis of the dose response and secondary endpoints to determine how
or if we will take this novel mechanistic approach forward,” said Mark
H.N. Corrigan, M.D., Executive Vice President, Research and Development
at Sepracor.
SEP-225289 is a member of a relatively new class of pharmacologic agents
referred to as triple reuptake inhibitors based on their activities at
the serotonin, norepinephrine and dopamine transporters. The
pharmacological profile of SEP-225289 is distinct from all other
currently approved antidepressant agents due to its significant affinity
for the dopamine transporter as well as its high potency reuptake
inhibition at the serotonin and norepinephrine transporters.
In 2008 and early 2009, Sepracor completed two pediatric studies of
LUNESTA® brand eszopiclone in response to a Written Request
from the United States Food and Drug Administration (FDA) in connection
with its efforts to obtain a pediatric exclusivity extension for
LUNESTA. In April 2009, Sepracor initiated two additional pediatric
studies in accordance with the FDA’s Written Request.
