Press Release: Schwartz Pharma Unveils Positive Phase III Data on Lacosamide
SCHWARZ PHARMA Unveils Positive Phase III Data on Lacosamide at North American Regional Epilepsy Congress in San Diego Monday December 4, 8:45 am ET SCHWARZ PHARMA presents positive Phase III data on lacosamide for the treatment of epilepsy at the 1st North American Regional Epilepsy Congress, December 1-5, 2006, in San Diego, USA. This trial will be part of the submission documents for marketing approval in Europe and the U.S. SAN DIEGO, Dec. 4 -- For the first time at the North American Regional Epilepsy Congress, SCHWARZ PHARMA presented results from one of its Phase III trials, which investigated the efficacy and safety of oral lacosamide as adjunctive therapy in adults with uncontrolled partial seizures. In this trial, both lacosamide 200 and 400 mg/day demonstrated statistically significant and clinically relevant improvements over placebo and were generally well tolerated when administered concomitantly to patients previously uncontrolled on 1-3 antiepileptic drugs (AEDs). These data were presented today in an oral presentation. "We are delighted that lacosamide has demonstrated efficacy in a very difficult-to-treat patient population. Lacosamide is a promising new compound with a novel mode of action, and it has the potential to play an important role in the management of epilepsy," said Iris Loew-Friedrich, MD, PhD, member of the Executive Board SCHWARZ PHARMA AG. "This trial will be submitted to the regulatory agencies in both the European Union and the U.S. as part of the marketing authorization application for lacosamide as adjunctive therapy in adults with partial seizures." Study Design and Results This multi-center, double-blind, placebo-controlled clinical trial performed in Europe and Australia included an eight-week baseline phase, four- week titration phase, twelve-week maintenance phase and either a two-week taper phase or a two-week transition into an open-label extension trial. Four hundred eighty-five adults with uncontrolled partial-onset seizures, who were on a stable regimen of 1-3 concomitant AEDs, were randomized to receive adjunctive treatment with placebo, 200 mg or 400 mg of oral lacosamide, in two equally divided doses per day. The primary efficacy variables were reduction of seizure frequency and responder rate (patients with at least a 50% reduction in seizures). The lacosamide 200 and 400 mg/day treatment groups were statistically significant over placebo in reducing seizure frequency from Baseline to Maintenance endpoint. The percent reduction in seizure frequency over placebo was 14.4% (P=.02) for the lacosamide 200 mg/day group and 15.0% (P=.03) for the lacosamide 400 mg/day group. Similar positive findings were observed for the 400 mg/day group in the statistical analysis of responders (patients with at least 50% seizure reduction from Baseline to Maintenance endpoint). The 50% responder rate for the 400 mg/day group was 40.5% versus 25.8% for the placebo group (P=.006). During the trial, lacosamide was generally well tolerated, with dizziness, headache and double vision being the most commonly reported adverse events. Adverse events often associated with antiepileptic treatments, somnolence and cognitive disorder, were notably low and similar to placebo. About Lacosamide Lacosamide is a novel, investigational compound that has been studied in Phase III trials. The results suggest efficacy in treating both epilepsy and painful diabetic neuropathy. Studies have indicated that lacosamide works through two unique and separate modes of action. Unlike traditional AEDs that affect sodium channel fast-inactivation, lacosamide is believed to selectively enhance slow-inactivation, thus reducing abnormal neuronal transmission in the brain. Additionally, lacosamide acts on a protein involved in neuronal growth (CRMP-2). The interaction of lacosamide with CRMP-2 may prevent the formation of abnormal neuronal connections in the brain. This could have a possible effect on the underlying disease. About Epilepsy "Epilepsy" is the name for a whole group of serious disorders, which may be inherited or caused by other factors such as trauma. An abnormal increase in the activity of the central nervous system leads to epileptic seizures, which are usually manifested as shaking or convulsions with impaired consciousness. Approximately 5-8% of the population will have a seizure once in their life. About 0.5-1.0% of the population will have recurrent seizures, which is necessary to diagnose epilepsy. Anticonvulsants serve to prevent epileptic seizures and are most often used as long-term therapy. SCHWARZ PHARMA (headquartered in Monheim, Germany) is a stock listed company with approximately 4,400 employees worldwide. The company develops novel medicines in the therapeutic areas of the central nervous system. Furthermore it markets innovative drugs focused to treat cardiovascular and gastro-intestinal diseases. In 2005 the SCHWARZ PHARMA group achieved global sales of nearly Euro 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia. Contact: Antje Witte, Tel: +49 2173 48 1866; Bettina Ellinghorst, Tel.: +49-2173 48 2329. For U.S. inquiries, Michael Davis, Tel: +1-262-238-5446. This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. 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