Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Dec 2 2009

Sepracor Inc. today announced that clinical study data for STEDESA^™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST. A separate Scientific Exhibit of STEDESA data will be held on Monday, December 7, 2009 from 8:00 am to 5:00 pm EST at the Sheraton Boston Hotel in Ballroom C and will include the posters presented during the poster session as well as additional posters of pharmacokinetic, safety and efficacy data and design posters for two ongoing trials.

Saturday, December 5, 2009 Poster Session:

• An Investigation of the Effects of Eslicarbazepine Acetate on Hyponatremia: A Pooled Analysis of Three Double-Blind Phase III Clinical Studies
• An Investigation of the Effect of Eslicarbazepine Acetate on Cardiac Repolarization: A Pooled Analysis of Over-Read Electrocardiograms From Three Double-Blind Phase III Clinical Studies
• An Evaluation of the Effect of Eslicarbazepine Acetate on Metabolic Parameters: A Pooled Analysis of Three Double-Blind Phase III Clinical Studies
• An Evaluation of Depressive Symptoms Following Treatment With Eslicarbazepine Acetate: A Pooled Analysis in the Open-Label Extensions of Three Phase III Studies in Subjects With Partial-Onset Seizures
• Incidence of Rash in the Pooled Population of Three Placebo-Controlled Phase III Clinical Trials With Eslicarbazepine Acetate
• An Investigation of the Therapeutic Effect of Eslicarbazepine Acetate Combined With Carbamazepine: Pooled Analysis of Three Placebo-Controlled Phase III Clinical Studies
• An Investigation of the Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Carbamazepine: A Pooled Analysis of the Three Placebo-Controlled Phase III Clinical Studies

Monday, December 7, 2009 Scientific Exhibit:

• Investigation of the Influence of Eslicarbazepine Acetate on the Plasma Concentrations of Concomitant Antiepileptic Drugs in Patients With Partial-Onset Epilepsy
• Pharmacokinetics of Eslicarbazepine Acetate in Subjects With Renal Impairment
• Effect of Eslicarbazepine Acetate on the Steady-State Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects
• A Double-Blind, Add-On, Placebo-Controlled, Exploratory Trial of Eslicarbazepine Acetate in Patients With Partial-Onset Seizures
• An Evaluation of the Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-On Treatment in Adults With Refractory Partial-Onset Seizures: Study BIA-2093-301
• Long-Term Treatment of Partial-Onset Seizures With Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension to Study BIA-2093-301
• Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment With Eslicarbazepine Acetate: Study BIA-2093-301
• Evaluation of Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-On Treatment in Adults With Refractory Partial-Onset Seizures: Study BIA-2093-302
• Long-Term Treatment of Partial-Onset Epilepsy With Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension of Study BIA-2093-302
• Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment With Eslicarbazepine Acetate: Study BIA-2093-302
• Evaluation of the Efficacy and Safety of Eslicarbazepine Acetate as Add-On Treatment in Patients With Partial-Onset Seizures: Pooled Analysis of Three Double-Blind Phase III Clinical Studies
• Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial
• Sepracor Study 093-045 Design Overview: Double-Blind, Randomized, Historical Control Study of Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current AEDs

The studies on which these analyses and posters are based were conducted by BIAL with editorial support for the posters provided by Sepracor.