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Phase 3 Trial To Be Initiated for Tiagabine in Anxiety Disorders
This eight-week, double-blind, randomized, multi-center, placebo- controlled Phase II study with a flexible-dose design included 260 adult patients with GAD. The study was designed to determine the dose, time of onset and magnitude of GABITRIL's effect in GAD.
"Statistically significant improvements were seen at several time points, including at week one, in patients receiving GABITRIL, versus those receiving placebo, as measured by the Hamilton Anxiety Scale (HAM-A)," said Dr. Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. "In addition, this Phase II study suggested that GABITRIL may have a favorable tolerability profile, as sexual dysfunction, changes in body weight and discontinuation syndrome were not observed.
"Based on the results of this study, we can now move forward with confidence to design and initiate a Phase III clinical program in anxiety," Blake added.
The Phase II clinical trial data in GAD will be discussed during Cephalon's live webcast of its analyst meeting at Noon EDT on Tuesday, April 13, 2004. To access the live webcast, including any presentation materials, visit the Investor Relations section at www.cephalon.com. A replay of the webcast will be available online until April 26th.
Generalized Anxiety Disorder
According to the National Institute of Mental Health (NIMH), Generalized Anxiety Disorder is characterized by chronic, exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with this disorder usually expect the worst; they worry excessively about money, health, family, or work, even when there are no signs of trouble. They are unable to relax and often suffer from insomnia. Many people with GAD also have physical symptoms, such as fatigue, trembling, muscle tension, headaches, irritability or hot flashes. According to NIMH, about 2.8 percent of U.S. adults have been diagnosed with Generalized Anxiety Disorder.
GABITRIL is a selective GABA-reuptake inhibitor (SGRI), which selectively inhibits the reuptake of gamma aminobutyric acid (GABA), thus increasing the levels of synaptic GABA. Abnormalities in GABA neurotransmission have been implicated in the pathophysiology of a variety of disorders, including epilepsy and anxiety. GABITRIL is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. 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.