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All active treatments were more sedating than placebo at 3, 4, and 5 hours. In quantitative EEG studies, both XR and IR administration, compared to placebo, resulted com buy xanax online in significan t differences in the percentage of beta-wave activity. However, at steady state, there were no significant differences in EEG effects between the two alprazolam formulations. Overall Data Data reviewed included those from 37 (13 Phase D/m & 24 Phase I) studies submitted in NDA 21,434.
For the primary analysis of efficacy, the pivotal study M/2000/0369 was reviewed in detail. Summaries of efficacy analyses were reviewed for 4 other "supportive studies." However, as these 4 studies failed on face, the efficacy data were not reviewed in detail.
Furthermore, the Division had required that the sponsor submit data from only one positive well-controlled trial for the purposes of establishing efficacy for this NDA.
For the primary safety analysis, safety data from all 37 alprazolalm XR studies were reviewed. In addition, literature searches were performed regarding the safety, efficacy, drug withdrawal ami discontinuation phenomenon, and abuse liability of treatment with alprazolam XR.
Finally, this review incorporates results of analyses performed by xanax bars lyrics reviewers in the following divisions: Biometrics (statistics), Biopharmaceutics, and the Division of Scientific Investigations (DSI). The table below lists com buy xanax online the trials that have been reviewed. Tables Listing the Clinical Trials Reviewed APPEARS THIS WAY ON ORIGINAL 1.
Review of Efficacy: the Pivotal Placebo-Controlled Study of XANAX XR in Panic Disorder (Study M/2000/0369) Study com buy xanax online Number Study Design Duration Treatment Regimen ITT: # of Patients M/2000/0369 Reviewed for efficacy & safety Randomized, D-B, P-C, Flexible Dose 6 weeks of treatment; 5 wk Discontinuation XANAX XR 1-10 mg QD 104 Placebo QD 96 2. Review of Safety: 4 Other Placebo-Controlled Studies of XANAX XR in Panic Disorder Study Number Study Design Duration Treatment Regimen U of Patients M/2000/0271 Reviewed for safety & discontinuation AE Randomized, D-B, P-C, Flexible Dose 6 weeks treatment; 16 weeks Discontinuation XANAX XR 1-10 mg/d 70 XANAX IR 1-10 mg/d BID . to 5 times daily 70 Placebo BID to 5 times daily 69 M/2002/0002 Reviewed for safety & discontinuation AE Randomized, D-B, P-C, Fixed Dose, Parallel Group 10 weeks treatment; 4 wk Discontinuation; 2 wk post-dc XANAX XR 4 mg/d BID 79 XANAX XR 4 mg/d BID 75 Placebo BID 74 M/2002/0003 Reviewed for safety & discontinuation AE Randomized, D-B, P-C, Fixed Dose, Parallel Group 10 wk treatment; 4 wk Discontinuation; 2 wk post-dc XANAX XR 4 mg/d QD 88 XANAX XR 6 mg/d QD 89 Placebo QD 81 M/2002/0032 Reviewed for safety & discontinuation AE Randomized, D-B, P-C, multiple ascending dose Cognitive- Behavioral Therapy 8 weeks treatment; 4 weeks Discontinuation XANAX XR4mg/d BID 23 Placebo BID 24 APPEARS THIS WAY ON ORIGINAL 3. Table of the 13 Phase IT/TTT Studies Reviewed for the Safety Analysis Table 1. of Treated Patients | Type of Study Studies [ref] ALP XR | ALP IR | Placebo | Other | Total | s ' -t , a 5 M/2000/0369  104 &9S3SS 96 200 Phase 3 Placebo - M/2000/0271  69 70 69 . 208 M/2002/0002  155 76 MWM& 231 Controlled M/2002/0003  178 AV3Kv 83 . fi! 261 M/2002/0032  25 7'7'>' Vi 25 FTrJl 50 Total 5 531 70 349 L 950 a Clomipramine b Bromazepam c Fluoxetine d Also received com buy xanax online Alprazolam IR In this IR-to-XR switch study e Lorazepam Source: Integrated Safety Database C.Postmarketing Experience There has been considerable post-marketing experience with alprazolam XR in other countries since 1994, when the drug was first approved in Finland. Registration approval has been granted for alprazolam XR in 51 countries for indications which vary by location. Indications include: Panic Disorder, anxiety, anxiety associated with depression, mixed anxiety-depression, or depression associated with functional or organ disease. There are a number of different trade names for the formulation: ALPRA PAN RETARD, TAFIL L1BERACION PRO, TAFIL RETARD, XANAX DEPOT, XANOR DEPOT, XANOR RETARD, TRANKIMAZIN RETARD, and ZOTRAN. Alprazolam XR has never been Tefused approval due to safety reasons, and it has never been removed from marketing.
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