AptiomTreatment for Epilepsy, Seizures
Update: Aptiom (eslicarbazepine acetate) Now FDA Approved - November 8, 2013
NDA Submitted for Stedesa
Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy
MARLBOROUGH, Mass. -- Mar 31, 2009 - Sepracor Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The proposed trade name for eslicarbazepine acetate is Stedesa.
"If approved, Stedesa has the potential to be a meaningful new treatment for patients with epilepsy," said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. "Clinical studies have indicated that Stedesa has the potential to reduce seizure frequency, provide simpler dosage titration and reduce side effects with once-daily dosing."
Stedesa, a new chemical entity, is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures.
"The NDA submission for Stedesa, subject to acceptance and approval by the FDA, represents a significant and near-term opportunity for Sepracor," said Adrian Adams, President and Chief Executive Officer of Sepracor. "This submission is another step forward in our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline, building a stronger and more productive commercial organization and continuing to execute strategically aligned corporate development and licensing initiatives."
Under the Prescription Drug User Fee Act, the FDA has 60 days after submission to review an NDA in order to determine if the application may be accepted for filing. The acceptance of the filing of an application means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.
In February 2009, the Committee for Medicinal Products for Human Use of the European Medicines Agency in the European Union (EU) issued a positive opinion to grant marketing authorization for Zebinix (EU-approved trade name for eslicarbazepine acetate) for adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization. BIAL-Portela & Ca, S.A. (BIAL), a privately held Portuguese pharmaceutical company, was responsible for the research and development and EU filing for eslicarbazepine acetate. Sepracor acquired the rights to commercialize eslicarbazepine acetate for the U.S. and Canadian markets from BIAL in late 2007.
Stedesa has been 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 seizures per month 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.
Sepracor is seeking approval of Stedesa for adjunctive therapy with once-daily maintenance doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.
About partial-onset seizures and their treatment
Epilepsy is one of the most common neurological diseases that, according to the Epilepsy Foundation, afflicts approximately 2.7 million people in the U.S. Treatment of partial-onset seizures, the most common type of epilepsy, presents a constant challenge – up to 58% of patients with partial-onset seizures do not achieve seizure control with current antiepileptic drugs.2 Patient compliance with antiepileptic agents represents a significant area of unmet need, with poorly compliant patients more likely to have breakthrough seizures3 and have higher mortality risk4. Additionally, patients with epilepsy often suffer from other concomitant diseases, further complicating the management of these patients.5 Finally, adverse events, such as dizziness and somnolence, are highly prevalent with existing antiepileptic agents and may affect as many as 97% of patients.6
Epilepsy is characterized by abnormal firing of impulses from nerve cells in the brain. In partial-onset epilepsy, these bursts of electrical activity are initially focused in specific areas of the brain, but may become more generalized; the symptoms vary according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane.
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® 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.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits, possible uses and commercial success of Stedesa; and Sepracor taking steps towards meeting its corporate objectives of expanding and advancing its pharmaceutical product pipeline, building a stronger and more productive commercial organization and continuing to execute strategically aligned corporate development and licensing initiatives. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of acceptance, and approval of the Stedesa NDA and other regulatory filings; the scope of Sepracor's trademarks, patents and the patents of others and the success of challenges by others of Sepracor's patents; the clinical benefits and commercial success of Sepracor's products; Sepracor's ability to successfully implement its recently announced corporate restructuring and workforce reduction plan and reduce expenses; the ability of Sepracor to attract and retain qualified personnel; the ability of Sepracor to successfully collaborate with third parties and enter into new collaboration arrangements; the performance of Sepracor's licensees and other collaboration partners, including BIAL; and certain other factors that may affect future operating results, which are detailed in Sepracor's Annual Report on Form 10-K for the year ended December 31, 2008 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.
1 Source: IMS Health, Verispan
2 Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30
3 Cramer JA, Glassman M, Rienzi V. The relationship between poor medication compliance and seizures. Epilepsy Behav. 2002;3:338-342
4 Faught E, Duh, M, Weiner J, Guerin A, Cunnington M. Nonadherence to antiepileptic drugs and increased mortality, Findings from the RANSOM Study. Neurology 2008; 71: 1572-1578
5 Gidal BE, French JA, Grossman P, Le Teuff G. Assessment of potential drug interactions in patients with epilepsy: Impact of age and sex. Neurology 2009; 72: 419-431
6 Mei PA, Montenegro MA, Guerreiro MM, Guerreiro CA. Pharmacovigilance in epileptic patients using antiepileptic drugs. Arq Neuropsiquiatr 2006 Jun;64(2A): 198-201. Epub 2006 Jun 9
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. Stedesa is a trademark and Zebinix is a registered trademark of BIAL-Portela & Ca, S.A. OMNARIS is a trademark and ALVESCO is a registered trademark 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.
Jonaé R. Barnes, 508-481-6700
Sr. Vice President, Investor Relations and
Posted: March 2009
- 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 Provides Complete Response to Sepracor's New Drug Application for Stedesa - May 4, 2010
- 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