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Age, gender, race, and concurrent illness did not affect the distribution of mean daily or mean to buy xanax online final dose in the active-controlled studies, uncontrolled study, or studies in other indications. of Treated Patients Studies [ref] ALP XR | ALPIR | Placebo | Other Total 8H Phase 3 Placebo - Controlled M/2000/0369 [25] M/200Q/0271 [26] 104 69 96 69 155 178 25 531 76 83 25 349 M/2002/0002 [27] M/2002/0003 [28] to buy xanax online M/2002/0032 [29] Total 129 13 142 29 Phase3 Active- Conlrolled M/2002/0015 [30] M/2000/0385 [31] phase 2 Active- Controlled Total Phased Open-Label 29° M/2002/0021 [32] to buy xanax online 29 59 29 32 54 113 264 966 Total % 51 • 10;;irr.Mr. Wjif-riiHTC M/2002/0014 [33] Generalized M/2002/0039 [34] Anxiety Disorder IRtoXR Switch In Anxiety M/2000/0365 [35] M/2002/0022 [36] MADD M/2002/0045 [37] Total 13 TOTAL All studies C.

Overview of Phase II/III Trials a.Placebo-Controlled Studies in Panic Disorder (M/2000/0369, M/2000/0271, M/2002/0002, M'2002/0003, and M/2002/0032) The grouping of primary interest consists of 5 Phase 3 placebo-controlled studies in panic disorder. The total number of treated patients in this group is 950; 531 were treated with alprazolam XR, 70 with alprazolam IR, and 349 with placebo.

b.Active-Controlled Studies in Panic Disorder (Studies M/2000/0385 & M/2002/0015) The second grouping consists of 2 active-controlled studies in panic disorder: a Phase 3 study with clomipramine as the comparator and a Phase 2 study with alprazolam IR as the comparator. The total number of treated patients in this grouping is 277. In the Phase 3 study, 129 patienls were treated with alprazolam XR and 128 with clomipramine; in the Phase 2 study, 13 patients were treated with alprazolam XR and 7 with alprazolam IR. c.Uncontrolled Study in Panic Disorder (Study M/2002/0021) One Phase 3 uncontrolled study.

In this IR-to-XR switch study, 29 patients were treated with both alprazola m XR and alprazolam IR.

d.Studies in Other Indications (Studies lvl/2002/0014, M/2002/0039, & M/2000/0365 [Generalized Anxiety Disorder]; Study M/2002/0022 [IR to XR switch in anxiety]; and Study M/2002/0045 [Mixed Anxiety-Depressive Disorder] The fourth and final grouping consists of 5 studies in other anxiety-related indications. The total number of treated patients in this group is 493; 264 were treated with alprazolam XR, 70 with bromazepam, 34 with lorazepam, and 125 with fluoxetine.

SAFETY INFORMATION FROM 24 PHASE I CLINICAL PHARMACOLOGY STUDIES The studies for the; biopharmaceutic/pharmacokinetic/pharmacodynamic development program for alprazolam XR tablets were conducted in healthy volunteers, under single- and multiple-dose conditions. Single to buy xanax online doses tested in these trials ranged from 0.5 to 10 mg. In summary, there were no deaths, to buy xanax online serious adverse events, or unexpected adverse events observed during the course of these 24 studies involving 598 subjects.

Eight (1%) subjects in the phiirmacokinetic/bioavailability studies dropped out because of medical events. Alprazolam XR tablets, in single doses ranging from 1 mg to 10 mg and in multiple doses ranging from 1 mg to 6 mg daily for 3 to 7 days, were well tolerated by the healthy subjects who participated in the pharmacokinetic /bioavailability studies. The adverse events that were reported during these studies were consistent with the known pharmacologic profile of alprazolam and with the study conditions that were imposed on the subjects. No serious, unexpected, or life-threatening adverse events occurred, and there were no deaths. Adequacy of Safety Testing & Analysis The methods of monitoring and analyzing potential safety concerns were adequate and appropriate in the placebo-controlled studies. The types and frequencies of safety assessments were sufficient. ECG studies in the placebo-controlled studies were not performed; however, there was adequate ECG information provided from other studies using alprazolam XR.



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