VIMPAT enjoys positive results in Phase 3 study

UCB has announced the results of its Phase 3 study of VIMPAT (lacosamide) to review the efficacy and safety of conversion to lacosamide monotherapy.

Adults with epilepsy who suffer partial-onset seizures took part in the work, which analysed those with or without secondary generalisation against those who have a historical control.

The primary endpoint of the study was to show the exit rate for patients on lacosamide was markedly lower than the historical control, and this target was met.

UCB is set to put forward this data as part of a New Drug Application for lacosamide to the US Food and Drug Administration.

Professor Dr Iris Loew-Friedrich, chief medical officer and executive vice president of UCB, said: "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.

"These encouraging data support our development program for lacosamide as monotherapy for partial onset seizures, starting in the United States."

The primary efficacy endpoint of the laboratory work was the percentage of patients who met a minimum of one of the defined exit criteria by day 112 in relation to the beginning of the removal of background antiepileptic drugs and historical control.

UCB's research will be followed with a complete efficacy and safety analyses. This will be put forward for presentation at an epilepsy meeting in the near future.

Epilepsy is a chronic neurological disorder that affects around 65 million people across the world, with 2.2 million of these in the US.

On the other hand, VIMPAT tablets were launched in the US in May 2009 as an add-on therapy for the treatment of the condition in people who are 17 and above.

Posted by Ben Evans