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XANAX® XR, CIV Clinical Studies (alprazolam)

14 CLINICAL STUDIES

The efficacy of XANAX XR in the treatment of panic disorder in adults was established in two 6-week, flexible-dose, placebo-controlled studies in adult patients meeting DSM-III criteria for panic disorder. In these studies, patients were treated with XANAX XR in a dose range of 1 mg to 10 mg once per day. The effectiveness of XANAX XR was assessed on the basis of changes in various measures of panic attack frequency, on various measures of the Clinical Global Impression, and on the Overall Phobia Scale. In all, there were 7 primary efficacy measures in these studies, and XANAX XR was superior to placebo on all 7 outcomes in both studies. The mean dose of XANAX XR at the last treatment visit was 4.2 mg per day in the first study and 4.6 mg per day in the second.

In addition, there were two 8-week, fixed-dose, placebo-controlled studies of XANAX XR in adult patients with panic disorder, involving fixed XANAX XR doses of 4 mg and 6 mg once per day that did not show a benefit for either dose of XANAX XR.

Analyses of the relationship between treatment outcome and gender did not suggest any differential responsiveness on the basis of gender.

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