Cephalon said that it will conduct a complete analysis of the data to assist in its evaluation of future clinical development plans for Gabitril in other therapeutic areas.
The company currently markets Gabitril in the US and Europe as adjunctive therapy in adults and children 12 years and older in the treatment of partial epileptic seizures.
In three multi center, double-blind, placebo-controlled, parallel-group clinical trials and two placebo-controlled crossover studies, Gabitril significantly reduced the frequency of seizures in patients with epilepsy who took the drug as add-on therapy.
In clinical trials, Gabitril was well tolerated with the most common adverse events being mild to moderate in severity. The most common adverse events were dizziness, asthenia (weakness), somnolence, nausea, nervousness, tremor, abdominal pain, and impaired concentration.