Healthcare Industry News: OMNARIS
News Release - June 19, 2008
Sepracor Announces Phase III Data for Eslicarbazepine Acetate Presented at Ninth Eilat Conference on New Anti-Epileptic DrugsPresentation summarized results of three Phase III studies of eslicarbazepine acetate in more than 1,000 patients with refractory partial epilepsy
Studies demonstrated marked and sustained seizure reduction and significant improvement in quality of life and depressive symptoms over a one-year treatment period
U.S. New Drug Application (NDA) submission targeted for late 2008 or early 2009
MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) today announced the presentation of Phase III combined clinical results for eslicarbazepine acetate (SEP-0002093 / BIA 2-093) in the treatment of epilepsy at the Ninth Eilat Conference on New Anti-Epileptic Drugs in Spain. Results of the studies demonstrated a significant reduction in the frequency of partial seizures in patients who were administered eslicarbazepine acetate in combination with other existing anti-epileptic drugs. These studies will be included in Sepracor’s NDA submission to the U.S. Food and Drug Administration (FDA), which is targeted for late 2008 or early 2009.
Patients enrolled in the three large-scale, Phase III studies had a history of more than four partial seizures per month despite treatment with up to three concomitant anti-epileptic drugs. In these studies, eslicarbazepine acetate once-daily at doses of 800 mg and 1200 mg significantly reduced seizure frequency over each 12-week maintenance period versus placebo. Furthermore, patients treated with eslicarbazepine acetate demonstrated sustained reduction in seizures over an open-label, one-year period, and eslicarbazepine acetate was generally well tolerated.
About the Studies
The three large-scale, randomized, double-blind, placebo-controlled, multi-center, add-on Phase III trials in partial epilepsy included an aggregate of 1,049 patients 18 years of age or older from 23 countries. Patients were randomized to eslicarbazepine acetate or placebo and then were followed up in an open-label study for one year.
In the intent-to-treat population (i.e. all patients in the study), there was a 35.4 percent relative reduction in seizure frequency over the 12-week period for the 800 mg once-daily dosage regimen (p=0.0002) and a 38.8 percent reduction for the 1200 mg once-daily dosage regimen (p=0.0001) compared with placebo. Furthermore, 36.3 percent of patients receiving 800 mg daily and 43.5 percent of patients receiving 1200 mg daily experienced a 50 percent or greater reduction in seizure frequency over the 12-week maintenance period (p=0.0001 and p<0.0001, respectively). Reduction in seizure frequency and responder rates were sustained over the 52-week treatment period. Patients administered eslicarbazepine acetate also demonstrated statistically significant improvements in mean quality of life as measured by Quality of Life in Epilepsy Inventory-31 (QOLIE-31) scores at Week 52 compared with baseline measures.
Results from the add-on Phase III studies in partial epilepsy are expected to be presented in further detail at the upcoming European Congress on Epileptology in Berlin in September and the American Epilepsy Society Annual Meeting in Seattle in December.
About Partial Seizures and Their Treatment
Epilepsy is one of the most common neurological diseases and, according to the Epilepsy Foundation, approximately 2.7 million people in the U.S. have epilepsy. Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge – up to 58 percent of patients with partial seizures do not achieve seizure control with current anti-epileptic drugs1. Furthermore, adverse events, such as dizziness and somnolence, are highly prevalent with existing anti-epileptic agents and may affect as many as 97 percent of patients2.
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, and symptoms vary according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane.
About Eslicarbazepine Acetate
Eslicarbazepine acetate is a novel, voltage-gated sodium channel blocker that has been studied to reduce the frequency of partial-onset seizures when used in combination with other anti-epileptic drugs. A Marketing Authorization Application for eslicarbazepine acetate was submitted to the European regulatory authorities in March 2008 by its innovator, Bial - Portela & Ca, S.A., a privately held Portuguese pharmaceutical company. Eslicarbazepine acetate, which Bial plans to market in the European Union under the name ZEBINIX™, is under review for the treatment of partial-onset seizures with or without secondary generalization in combination with other anti-epileptic drugs. Sepracor acquired the rights to commercialize eslicarbazepine acetate for the U.S. and Canadian markets and is targeting submission of an NDA to the FDA at the end of 2008 or in early 2009.
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 and OMNARIS™ brand ciclesonide Nasal Spray. 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 and potential benefits of eslicarbazepine acetate; and the possible submission of an NDA for eslicarbazepine acetate in late 2008 or early 2009. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: clinical benefits, efficacy and safety of eslicarbazepine acetate; the timing and success of submission, acceptance, and approval of regulatory filings for eslicarbazepine acetate; unexpected delays in commercial introduction of, and the commercial success of, eslicarbazepine acetate; the success of Sepracor’s alliance with Bial; the scope of Bial’s and/or Sepracor’s patents and the patents of others; the ability of Sepracor and Bial to attract and retain qualified personnel; and certain other factors that may affect future operating results that are detailed in Sepracor’s quarterly report on Form 10-Q for the quarter ended March 31, 2008 filed with the Securities and Exchange Commission.
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.
Zebinix is a trademark of Bial - Portela & Ca, S.A. Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc. OMNARIS is a trademark of Nycomed GmbH.
1 Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30
2 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
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