SAN DIEGO, Dec. 5 /PRNewswire/ -- As part of its ongoing scientific research program for lacosamide, SCHWARZ PHARMA presented an overview of comprehensive pre-clinical and clinical data at the North American Regional Epilepsy Congress, including a positive Phase III trial, which suggested that lacosamide was both efficacious and well tolerated when added to drug regimens of subjects previously uncontrolled on 1-3 antiepileptic drugs (AEDs). Other highlights included data presentations on lacosamide's mode of action, pre- clinical efficacy for various seizure types and neurological disorders, and Phase II and III clinical trials investigating lacosamide for epilepsy and painful distal diabetic neuropathy.
"The studies presented at the North American Regional Epilepsy Congress strongly support the clinical development of lacosamide, a novel compound with a dual mode of action, for both epilepsy and diabetic neuropathic pain," said Iris Loew-Friedrich, MD, PhD, member of the Executive Board SCHWARZ PHARMA AG. "The Phase III studies presented at the meeting will become part of the marketing authorization applications for lacosamide in both the European Union and United States."
Pre-Clinical Data Summary Following are highlights from the pre-clinical data presentations: -- Lacosamide appears to have two novel modes of action. Unlike other drugs that treat epilepsy and diabetic neuropathic pain, lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, and modulates collapsin response mediator protein 2 (CRMP-2) -- Lacosamide was shown to have potent and broad neuroprotective effects in-vitro and in animal models, which may positively influence the pathogenesis of epilepsy with long-term use -- Combinations of lacosamide with other antiepileptic drugs were associated with potential synergistic anticonvulsant effects -- Lacosamide was highly-active in multiple pre-clinical models of different seizure types and attenuation of seizure spread. Additionally, lacosamide did not induce negative central nervous system (CNS) effects at therapeutic doses -- Lacosamide showed potent and broad effects in animal models for essential tremor, tardive dyskinesia, schizophrenia, and anxiety Clinical Data Summary Following are highlights from the clinical data presentations: Epilepsy -- A pivotal Phase III trial evaluating oral lacosamide 200 and 400 mg/day as adjunctive therapy in adults with uncontrolled partial seizures demonstrated statistically significant and clinically relevant improvements over placebo. Lacosamide was generally well tolerated when administered concomitantly with 1-3 antiepileptic drugs -- In a multi-center, open-label, Phase III trial, the safety profile for lacosamide solution for intravenous infusion was shown to be comparable to oral lacosamide tablets and was generally well tolerated -- An interim analysis of an ongoing, open-label, multi-center Phase II extension trial (SP 615) suggests that lacosamide greater than or equal to 200 mg/day may be well tolerated as long-term adjunctive treatment for patients with partial seizures -- A pharmacokinetic analysis from a multi-center, double-blind trial showed that concomitant antiepileptic drug plasma concentrations were not affected by oral lacosamide treatment Diabetic Neuropathic Pain -- A multi-center, double-blind, placebo-controlled Phase III trial demonstrated that lacosamide 400 mg/day significantly reduced pain scores in patients with diabetic neuropathy, and the effect was sustained over an 18-week treatment period 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.
In epilepsy patients, lacosamide was generally well tolerated. Dizziness, headache and nausea were the most commonly reported side effects across all treatment groups. In DNP patients, incident rates of individual adverse events were similar between the placebo, 200 and 400 mg/day groups, but were higher with the 600 mg/day dose. The most common treatment emergent adverse events included dizziness, nausea, fatigue and headache.
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.
About Diabetic Neuropathic Pain
Approximately 11 million patients worldwide suffer from diabetic neuropathic pain (DNP), a common and chronic condition associated with blood glucose levels that are or have been out of control. DNP is thought to result from permanently damaged nerves, which cause sensations such as numbness, tingling, burning or aching in the extremities. For many patients, diabetic neuropathic pain is intolerable. Daily life activities and quality of life can be severely affected. Patients with DNP often require long-term treatment to manage the pain associated with the condition.
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.
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