Schwarz Pharma says it should be able to press ahead with filing for approval of its epilepsy drug candidate lacosamide after a Phase III study showed it could cut seizure frequency.

The clinical trial backed up earlier data and met its key objectives of demonstrating a significant benefit from the drug in reducing seizures and increasing the proportion of patients who achieved a 50% improvement in symptoms.

Schwarz Pharma said it would “ask the regulatory agencies to consider this trial to be the second pivotal trial in the marketing application for adjunctive therapy in adults with partial seizures.”

The drug is expected to be a big seller for Schwarz, with sales potential of 300 million euros in epilepsy, helped by a favourable side effect profile which could help it compete against Pfizer’s rival drug Lyrica (pregabalin), launched in Europe in 2004 and the USA last April. Lyrica achieved sales of $291 million last year.

Schwarz said lacosamide was well tolerated in the Phase III trial, with the most common side effects being dizziness, nausea and vomiting.

Lacosamide could also reap a further 600 million euros if it also reaches the market for neuropathic pain, a secondary indication, according to Schwarz.