September 25, 2008
Bial Reports Positive Results From Phase III Studies of Seizure Drug
Bial, a Portuguese pharmaceutical company, has reported positive data from three Phase III studies which showed that Zebinix, a once daily anti-epileptic agent, has significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy, in combination with other anti-epileptic agents.
In addition, treatment with Zebinix also significantly improved patient quality of life, reduced depressive symptoms and demonstrated sustained reduction in partial seizure frequency during a one-year open label period.
The three Phase III, multi-center, randomized, placebo controlled trials involved more than 1,000 patients from 23 countries. Patients had a history of at least four partial seizures per month despite treatment with up to three concomitant anti-epileptic drugs.
During the trials, patients were randomized to eslicarbazepine acetate or placebo and after a two-week titration period, were assessed over a 12-week maintenance period, with continued follow-up over a one year open-label period.
Over the 12-week maintenance period, Zebinix 800mg and 1200mg reduced seizure frequency by over one third, and was significantly more effective than placebo. This significant decrease in seizure frequency was sustained over the one-year open label treatment period and was consistent regardless of baseline therapy. Similar positive findings were observed in the responder rate (greater-than-or-equal-to 50% decrease in seizure frequency) for Zebinix 800mg and 1200mg that ranged between 32% and 43% across all three Phase III trials.
Zebinix is currently under review by the European Medicines Agency for the treatment of partial-onset seizures with or without secondary generalization in combination with other anti-epileptic drugs. A US new drug application is expected later in 2008 or early 2009.