AptiomTreatment for Epilepsy, Seizures
Update: Aptiom (eslicarbazepine acetate) Now FDA Approved - November 8, 2013
Complete Response Letter for Stedesa NDA
FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa
MARLBOROUGH, Mass.--(BUSINESS WIRE)--May 3, 2010 - Sepracor Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA, or Agency) has issued a Complete Response Letter to Sepracor's New Drug Application (NDA) for its antiepileptic drug candidate, Stedesa, which is the company's proposed trade name for eslicarbazepine acetate.
The FDA issued a Complete Response Letter to the Stedesa NDA indicating that its initial review of the NDA is complete but that the Agency will not approve the application at this time. Sepracor will meet with the FDA to discuss the Complete Response Letter.
"While we are disappointed by this decision, we are committed to working closely with the FDA to gain approval of Stedesa, which we continue to believe has significant potential to address the continuing unmet need in the treatment of patients with epilepsy," said Saburo Hamanaka, Chairman and Chief Executive Office of Sepracor.
About the Stedesa clinical development program
Stedesa was studied in three Phase III, multi-center, randomized, placebo-controlled trials, which involved more than 1,000 patients from 23 countries. Patients involved in the trials had a history of at least four partial-onset seizures per month and no seizure-free period of more than 21 days despite treatment with one to three concomitant antiepileptic drugs. During the trials, patients were randomized to eslicarbazepine acetate or placebo, and after a 2-week titration period, were assessed over a 12-week maintenance period with continued follow-up over a one-year, open-label period.
BIAL-Portela & Ca, S.A. (BIAL), a privately held, research-based Portuguese pharmaceutical company, was responsible for the research and development of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Sepracor acquired the rights to further develop and commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL in late 2007.
About Sepracor Inc.
Sepracor Inc., an indirect, wholly owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., 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, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol, BROVANA® brand arformoterol tartrate Inhalation Solution, OMNARIS® brand ciclesonide Nasal Spray and ALVESCO® brand ciclesonide HFA Inhalation Aerosol. Sepracor's corporate headquarters are located in Marlborough, Massachusetts. For more information, please visit Sepracor's website at www.sepracor.com.
About Dainippon Sumitomo Pharma Co., Ltd. (DSP)
DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP's strong research and development presence in the areas of CNS, diabetes, cardiovascular disease, and inflammation/allergy, is based on the merger in 2005 between Sumitomo Pharmaceuticals Co., Ltd., and Dainippon Pharmaceutical Co., Ltd. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at www.ds-pharma.co.jp.
Stedesa is a trademark of BIAL-Portela & Ca, S.A. LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH.
For a copy of this release or any recent release,
visit Sepracor's web site at www.sepracor.com.
Contact: Sepracor Inc.
Susan Adler, 508-481-6700
Vice President, Corporate Planning and Communications
Posted: May 2010
- Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older - September 14, 2017
- FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures - August 28, 2015
- FDA Approves Aptiom to Treat Seizures in Adults - November 8, 2013
- Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy - March 8, 2013
- FDA Extends PDUFA Action Date for Stedesa New Drug Application - January 29, 2010
- Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA - June 1, 2009
- Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy - March 31, 2009