AptiomTreatment for Epilepsy, Seizures
Update: Aptiom (eslicarbazepine acetate) Now FDA Approved - November 8, 2013
Stedesa NDA Accepted for Review
Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA
Submission includes data from three Phase III studies in more than 1,000 patients from 23 countries
More than 3 million people in the U.S. are afflicted with epilepsy and seizures1
U.S. epilepsy treatment market estimated to be $3.5 billion2
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jun 1, 2009 - Sepracor Inc. (Nasdaq: SEPR) today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Stedesa (eslicarbazepine acetate) has been accepted for filing and is now under formal review. As previously announced, the NDA for Stedesa was submitted to the FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The acceptance of the filing means that the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
The Prescription Drug User Fee Act (PDUFA) date for Stedesa is expected to be January 30, 2010, subject to written confirmation. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission.
"We are very pleased to continue the advancement of Stedesa as a potential new adjunctive treatment for partial-onset epilepsy," said Adrian Adams, President and Chief Executive Officer of Sepracor. "Stedesa represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline."
Stedesa, a new chemical entity, is a novel voltage-gated sodium channel blocker. 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-onset 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.
BIAL-Portela & Ca, S.A. (BIAL), a privately held Portuguese pharmaceutical company, was responsible for the research and development of eslicarbazepine acetate. Sepracor acquired the rights to commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL in late 2007.
Sepracor is seeking approval of Stedesa for adjunctive therapy with once-daily 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 more than 3 million people in the United States. 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.3 Patient compliance with antiepileptic agents represents a significant area of unmet need, with poorly compliant patients more likely to have breakthrough seizures4 and have higher mortality risk5. Additionally, patients with epilepsy often suffer from other concomitant diseases, further complicating the management of these patients.6 Finally, adverse events, such as dizziness and somnolence, are highly prevalent with existing antiepileptic agents and may affect as many as 97% of patients.7
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, with symptoms varying 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 the safety, efficacy, potential benefits, possible uses and commercial success of Stedesa; the expected January 30, 2010 PDUFA date for Stedesa; Stedesa representing a significant and near-term opportunity for Sepracor; and the NDA application being a step forward in meeting one of Sepracor's near- and mid-term corporate objectives of expanding and advancing its pharmaceutical product pipeline. 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 (including BIAL's) and the success of challenges by others of Sepracor's and BIAL's patents; the clinical benefits and commercial success of Sepracor's (and its partners') 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 BIAL and other 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 filed with the 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 The Epilepsy Foundation of America® web site http://www.epilepsyfoundation.org/about/statistics.cfm, accessed May 27, 2009
2 Source: IMS Health, Verispan
3 Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30
4 Cramer JA, Glassman M, Rienzi V. The relationship between poor medication compliance and seizures. Epilepsy Behav. 2002;3:338-342
5 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
6 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
7 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 of BIAL-Portela & Ca, S.A. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH. The Epilepsy Foundation of America is a registered trademark of Epilepsy Foundation of America Corporation.
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: June 2009
- 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 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 Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy - March 31, 2009