Sepracor Provides Update on Clinical Trials for SEP-225289 and LUNESTA Pediatrics
MARLBOROUGH, Mass., Jul 01, 2009 (BUSINESS WIRE) -- Sepracor Inc. /quotes/comstock/15*!sepr/quotes/nls/sepr (SEPR 15.32, -2.57, -14.37%) 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(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.
"We are focusing our near-term research and development efforts on STEDESA(TM), which is a potential new adjunctive treatment for partial-onset epilepsy currently under review at the FDA, and OMNARIS(R) 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."
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA(R) brand eszopiclone, XOPENEX(R) brand levalbuterol HCl Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate Inhalation Aerosol, BROVANA(R) brand arformoterol tartrate Inhalation Solution, OMNARIS(R) brand ciclesonide Nasal Spray and ALVESCO(R) brand ciclesonide HFA Inhalation Aerosol. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect the safety, efficacy, potential benefits, possible uses and commercial success of SEP-225289, STEDESA and OMNARIS HFA Nasal Aerosol; Sepracor's near-term research and development efforts on STEDESA and OMNARIS HFA Nasal Aerosol; the timing of the second large-scale Phase II clinical study for OMNARIS HFA Nasal Aerosol; Sepracor's further investigation of the dose exposure relationship of SEP-225289 and secondary endpoints in the Phase II study; and Sepracor's ability to address FDA's concerns regarding the non-clinical data that could be relevant to the administration of eszopiclone in children. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: results from further analysis of the SEP-225289 Phase II study, including dose response and secondary endpoints; Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of the development of OMNARIS HFA Nasal Aerosol and the FDA's review of the STEDESA New Drug Application; the scope of Sepracor's and its collaboration partners' trademarks, patents and the patents of others; the success of challenges by others of Sepracor's and its collaboration partners' patents; the clinical benefits and commercial success of Sepracor's and its collaboration partners' products; the ability of Sepracor to attract and retain qualified personnel; the ability of Sepracor to successfully collaborate with BIAL-Portela & Ca, S.A. (BIAL) and Nycomed GmbH (Nycomed) for STEDESA and OMNARIS HFA Nasal Aerosol, respectively; the performance of Sepracor's collaboration partners, including BIAL and Nycomed; and certain other factors that may affect future operating results, which are detailed in Sepracor's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 filed with the Securities and Exchange Commission (SEC), and other reports filed with the SEC.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH. STEDESA is a trademark of BIAL-Portela & Ca, S.A.