New Data Show Efficacy of Zebinix(TM) in the Treatment o...(ibits therapid firing nerve cells that c...),Health

Date:9/24/2008

ibits the rapid firing nerve cells that cause seizures, has been developed to address the need for a new anti-epileptic agent that offers a reduction in seizure frequency combined with a favourable tolerability profile. Zebinix(TM) is currently under review by the EMEA (European Medicines Agency) for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs. A US NDA (New Drug Application) is expected later in 2008 or early 2009.

About the trials

The three phase III, multi-centre, randomised, 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.(2,3,4)

During the trials, patients were randomised to eslicarbazepine acetate or placebo and after a 2-week titration period, were assessed over a 12 week maintenance period, with continued follow-up over a one year open-label period.(2,3,4,7)

Efficacy

Over the 12 week maintenance period, Zebinix(TM) 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..(2,3,4) Similar positive findings were observed in the responder rate (greater-than-or-equal-to 50% decrease in seizure frequency) for Zebinix(TM) 800mg and 1200mg that ranged between 32% and 43% across all three phase III trials. (2,3,4)

Tolerability

The safety profile of Zebinix(TM) was favourable. The majority of treatment related adverse events were mild or moderate in severity and after 6 weeks, no relevant differences in the incidence of adverse events were apparent between patients treated with eslicarbazepine acetate and patients treated with placebo. In patients treated with Zebi
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