This was a multicenter, open-label, randomized crossover trial comparing two treatments,
Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking
conventional immediate-release alprazolam tablets for anxiety. The trial included five
study visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1
(Visit 2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5
[telephone visit]). At Visit 1, following screening, eligible subjects continued to take
their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible
subjects were randomized in approximately equal numbers to one of two treatment sequences:
Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT.
Subjects continued taking alprazolam in accordance with the treatment sequence to which they
were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3,
subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects
completed the Subject Preference Questionnaire, and a physical examination and clinical
laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own
conventional alprazolam. The site made a follow-up telephone call 7 - 3 days after Visit 4
to assess the subject's health status.
See approved Package Insert for Adverse Event information.
- Currently being treated with conventional alprazolam
- Dose of greater than 10 mg