ATLANTA and BRUSSELS, March 5,2013 /PRNewswire/ -- regulated information UCB today announced positive results of a Phase 3 study designed to evaluate the efficacy and safety of conversion to lacosamide monotherapy in adult patients with partial-onset seizures with or without secondary generalization compared with a historical control. The study met its primary endpoint demonstrating that the exit rate for patients on lacosamide (400 mg/day) was significantly lower than the historical control. UCB plans to submit these data as part of its supplemental New Drug Application for lacosamide to the U.S. Food & Drug Administration (FDA), which is planned in the second half of 2013.
"We are very pleased with these top-line results and look forward to discussing the detailed study results with the regulatory agencies and the scientific community," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB. "These encouraging data support our development program for lacosamide as monotherapy for partial onset seizures, starting in the United States. Lacosamide is currently approved in 36 countries as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy; UCB's comprehensive development program aims to make the product available to many more people living with epilepsy worldwide."
The Phase 3 study was an international, historical-controlled, multicenter, double-blind, randomized trial evaluating lacosamide (400mg/day) for conversion to monotherapy in 427 patients, aged 16-70 years with partial-onset seizures taking one to two other anti-epileptic drugs (AEDs). A lacosamide 300 mg/day arm was added to blind the treatment group and to ensure a study design consistent with the historical control studies on which the conversion to lacosamide monotherapy study was based.
The primary efficacy endpoint of the study was the percentage of patients who met at least one of the defined exit criteria by Day 112 relative to the start of withdrawal of background antiepileptic drugs and compared with the historical control. Patients were evaluated from the first day of tapering of the background AEDs and required to discontinue the study if they experienced any of the protocol exit events defined by seizure frequency, duration or severity.
These topline results will be followed by full efficacy and safety analyses, which will be submitted for presentation at an upcoming epilepsy meeting.
Lacosamide (tradename VIMPAT) is approved as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (ages>17 years in the U.S., ages>16 years in the EU). Lacosamide is not currently approved for use as monotherapy. Important safety information for lacosamide is available below.
About EpilepsyEpilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and 2.2 million people in the U.S.making it more common than autism, cerebral palsy, multiple sclerosis and Parkinson's disease combined. Anyone can develop epilepsy; it occurs across all ages, races and genders and is defined as two or more unprovoked seizures.
About VIMPATVIMPAT tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. VIMPAT injection is a short-term replacement when oral administration is not feasible in these patients. VIMPAT oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment. Important safety information about VIMPAT in the U.S. is available below.
In the European Union, VIMPAT (film-coated tablets, syrup and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT solution for infusion may be used when oral administration is temporarily not feasible. Important safety information about VIMPAT in the EU is available below.
Important safety information about VIMPAT in the U.S.
Go here to read the rest:
VIMPAT® (lacosamide) generates positive results in U.S. Phase 3 monotherapy study