UCB and Schwarz Pharma apply for Vimpat EU approval

UCB has announced that – through its Schwarz Pharma subsidiary – it has submitted an application for marketing authorisation with the European Medicines Agency for Vimpat (lacosamide) as a treatment for diabetic neuropathic pain.

This application has been accepted for review by the regulatory authority and it follows an earlier application with the European body in May 2007 for the drug as a treatment for adult epilepsy patients with partial onset seizures.

Lacosamide is an orally-administered anticonvulsant drug with an innovative dual mode of action, operating on collapsing response mediator protein 2 and sodium channel slow inactivation.

The company has already started proof-of-concept studies for the compound in other indications, including fibromyalgia, migraine prophylaxis and osteoarthritis, with the first results from these trials expected in 2008.

Iris Loew-Friedrich, global head of development of UCB, said: “Treatment with Vimpat significantly reduced pain in patients with diabetic neuropathic pain during the clinical trial program, which included more than 1,500 patients.”

She added that this application for marketing approval will be followed by a filing with the US regulatory authorities in the fourth quarter of the year.

In February 2007, Schwarz Pharma announced positive preliminary results of a phase III clinical trial of lacosamide in diabetic neuropathy patients, with administration of the drug resulting in a significant reduction in pain scores.