Sepracor Provides Update on Clinical Trials for SEP-225289 and LUNESTA® Pediatrics
News Jul 03, 2009
Sepracor Inc. has 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. The positive control in the study 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.
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.
“We are focusing our near-term research and development efforts on STEDESA™, which is a potential new adjunctive treatment for partial-onset epilepsy currently under review at the FDA, and OMNARIS® HFA Nasal Aerosol for the treatment of allergic rhinitis, which is on target to enter its second large-scale Phase III clinical study in the fall of 2009,” said Adrian Adams, President and Chief Executive Officer of Sepracor.
“We will provide an update on the ongoing analysis of the SEP-225289 data and the LUNESTA pediatric studies during our second quarter 2009 conference call that will be held later in July. In addition, we will provide a general review of progress with our pharmaceutical product pipeline.”