Zebinix (eslicarbazepine acetate) is a new kind of epilepsy drug--a novel voltage-gated sodium channel blocker designed to reduce frequency of partial-onset seizures when used in combination with other anti-epileptic drugs. (Zebinix is the trade name BIAL will use in European drug applications; Sepracor has not released the trade name it wants to use in the U.S. and Canada.)
At two recent professional meetings in Europe and the U.S., BIAL and Sepracor reported that data from three Phase 3 studies of once-daily eslicarbazepine taken with other epilepsy drugs significantly reduced frequency of partial seizures and showed potential to significantly improve quality of life and depressive symptoms in patients with uncontrolled partial-onset seizures. The companies presented data from a large number of studies to demonstrate the drug’s efficacy and safety.
Given once daily in doses of 800 mg or 1200 mg, eslicarbazepine significantly reduced the frequency of partial seizures by more than one-third during the study’s 12-week maintenance period and that reduction in seizure frequency was sustained over a one-year treatment period. Company officials said the one-year sustained reduction was demonstrated in all three Phase 3 studies.
How It Works
Eslicarbazepine acetate selectively inhibits the rapid firing of nerve cells that causes seizures. It has been developed to address the need for a new anti-epileptic agent that can offer a reduction in seizure frequency combined with a favorable side effect profile.
The three late-stage Phase 3 clinical trials involved more than 1,000 patients from 23 countries. The patients had a history of at least four partial seizures per month despite treatment with up to three other anti-epileptic drugs at the same time. In addition to reporting on the drug’s effectiveness, company officials said the safety profile was favorable, with most treatment-related adverse events mild or moderate in intensity.
Researchers also assessed the drug’s effect on quality of life and depressive symptoms. They found a statistically and clinically significant improvement in quality of life from baseline during long-term treatment, including improvements in seizure worry, emotional well-being, energy/fatigue, medication effects, and social function.
Improvement in depressive symptoms was seen in a statistically significant improvement from baseline and improvements in pessimistic thoughts, concentration difficulties, apparent sadness, and inner tension.
Important to Cut Seizure and Improve Life
“The impact of epilepsy on quality of life and the development of depression cannot be overestimated,” says Yale University School of Medicine research scientist Joyce Cramer, president of The Epilepsy Therapy Project, in a BIAL news release. “During clinical studies, Zebinix has demonstrated that in addition to effective seizure control and good tolerability, it also provides significant improvement in quality of life and a reduction in depressive symptoms in long-term follow-up. Zebinix has the potential to become an important treatment option for patients with epilepsy who are not achieving seizure control with their existing medications.” Cramer was the lead researcher who presented one of the studies at the 8th European Congress of Epileptology in Berlin, Germany.
Epilepsy is one of the most common neurological diseases, affecting nearly one in 100 people. An estimated 2.7 million people in the U.S. have epilepsy. Doctors say that treating partial seizures, the most common type of epilepsy, is a constant challenge and up to two-thirds of patients with partial seizures don’t achieve seizure control with current anti-epileptic drugs. Also, adverse events such as dizziness, sleepiness, and cognitive slowing are highly prevalent with existing anti-epileptic drugs and may affect 97% of patients. Thus, physicians have encouraged development of new drugs that can reduce seizure frequency and have a favorable safety profile.
Epilepsy is characterized by abnormal firing of impulses from brain nerve cells. In partial-onset epilepsy, these bursts of electrical activity are first focused in specific areas of the brain but can become more generalized. Symptoms vary according to the affected area. Nerve impulses are triggered through voltage-gated sodium channels in the nerve cell membrane and eslicarbazepine blocks those channels.
“These data suggest that eslicarbazepine acetate has the potential to become an important treatment option for patients in North America whose seizures are not adequately controlled with existing anti-epileptic agents,” Sepracor executive vice president for research and development Mark Corrigan said in a company release. “In addition, we plan to conduct monotherapy and pediatric studies with the goal of broadening eslicarbazepine acetate’s potential use.”
