Sepracor (SEPR) Sinks After SEP-22528 Fails To Meet Endpoint and Two Lunesta Studies Put On Hold
Shares of Sepracor, Inc. (Nasdaq: SEPR) have re-opened and are trading lower after an update on Clinical Trials for SEP-225289 and LUNESTA. Shares are down 16% to $15 per share.
Sepracor 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.
In 2008 and early 2009, Sepracor completed two pediatric studies of LUNESTA(R) 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. The FDA has notified us that these two studies have been put on clinical hold due to its concerns regarding non-clinical data that could be relevant to the administration of eszopiclone in children. The clinical hold does not relate to any findings observed in the pediatric clinical studies nor does it impact any ongoing eszopiclone clinical trials in adults. In addition, this action does not impact the availability or prescribing information for LUNESTA in the treatment of adults with insomnia. LUNESTA has been proven to be safe and well tolerated in the treatment of adults and elderly patients with insomnia. Sepracor intends to work with the FDA to address the potential resolution of FDA's concerns regarding the non-clinical data with respect to human pediatric subjects.
Sepracor 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.
In 2008 and early 2009, Sepracor completed two pediatric studies of LUNESTA(R) 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. The FDA has notified us that these two studies have been put on clinical hold due to its concerns regarding non-clinical data that could be relevant to the administration of eszopiclone in children. The clinical hold does not relate to any findings observed in the pediatric clinical studies nor does it impact any ongoing eszopiclone clinical trials in adults. In addition, this action does not impact the availability or prescribing information for LUNESTA in the treatment of adults with insomnia. LUNESTA has been proven to be safe and well tolerated in the treatment of adults and elderly patients with insomnia. Sepracor intends to work with the FDA to address the potential resolution of FDA's concerns regarding the non-clinical data with respect to human pediatric subjects.
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