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Robert Levin, the pivotal efficacy trial (protocol M/2000/0369 [4452]) for Alprazolam XR tablet was carried out with a,once daily regimen. At the pre-NDA meeting, discount pharmacy tramadol the Clinical Division informed the sponsor ' - dosing regimen for XR will be acceptable discount pharmacy tramadol if plasma profiles of XR given bid are completely bracketed by XR (qd) and IR (approved dosing regimen). 4.4.8.2Are plasma profiles of XR given bid completely bracketed by XR (qd) and IR (approved dosing regim en)?

From the Clinical Pharmacology and Biopharmaceutics perspective, are the proposed dosing regimen adequate (once daily or total daily dose given- divided doses)? [R/2002/0002& P/2002/0010 (Hossain's review); Pharmacometrics review (Mishina); Antal EJ et al & Greenblatt DJ et al (Chou's review )] Note: • Pharmacometrics (PM) consult was requested to evaluate whether it is acceptable regarding sponsor's justification and - losing with XR product [only qd dosing was tested in pivotal clinical trial (#4452)] based on population PK/PD of Xanax IR in the panic disorder patient population, and PK data observed from the once- and twice daily regimens of XR tablets. PM scientist was also asked to look at the potential PD effects if profiles are not completely bracketed.

These results along with the single efficacy clinical trial (#4452) have been submitted to support the approval of the Xanax XR (once- and ' dosing in panic disorders). Complete PM review is attached (Pharmacometrics review, section 7.4, page 70). • Previously, from the PK perspective, Hossain recommended: ' tot the qd dosing regimen. Specifically,.administration of one 3mg XR tablet twice a day resulted in an AUC, Cmax, Cmin and peak to trough fluctuation ratio (lower by 10%) that were not significantly different from the 1.5 mg qid dosing. However, once a day dosing of two 3mg XR tablets results in a 17% lower Cmin and a 32% greater peak to trough fluctuation ratio to a 1.5mg IR tablet qid. Yes, from the Clinical Pharmacology and Biopharmaceutics perspective, the pharmacokinetic parameters (the overall AUC, Cmax, of tramadol hcl in and Cmin) following the twice daily (bid) dosing are bracketed by those from XR (qd) and IR (qid) regi mens if same daily dose is administered. However, these data analyses have some limitations, i.e., the time-course of the effect was not taken into consideration.

Specifically, from the steady-state alprazolam plasma concentration profiles, plasma concentrations followed XR (bid) dosing are consistently the highest among three treatments (XR bid, XR qd , and IR qid) discount pharmacy tramadol between the hours of 14 -24 over discount pharmacy tramadol a 24-hour time span if the time-course after the dosing is considered. However, the potential impact on the safety from these sustained higher alprazolam levels is unknown and needs to be further evaluated by the Clinical Division. Summarized below are points to be considered: (a)Although the PK profiles as well as the calculated PD effects for alprazolam obtained after the administration of IR (1.5mg qid) and XR (3mg bid, 6mg qd) formulations discount pharmacy tramadol are similar, the conclusion of the same efficacy and safety of both formulations may be controversial since these comparisons did not take time-course of effect into consideration (Pharmacometrics review, section 7.4, page 70). (b)The data analysis such as 90% Cl of the overall average PK parameters (AUC, Cmax and Cmin) does not take time-course of effect into consideration. (c)The data from the two literature references (Antal EJ et al & Greenblatt DJ et al) the sponsor submitted suggested that the emergency .of several side effects, including sedation, was significantly related to alprazolam concentration following IR tablets (l-10mg/day) administration. The frequency of reports on the CNS-depressant side effects (sedation, ataxia, slurred speech, fatigue, and weakness) increased with higher alprazolam plasma concentration. Approximately 14.5% of patients experienced severe sedative effects at alprazolam level of 60ng/ml or greater, compared with 7.2% of the patients at level below 60ng/ml (p60ng/ml), however, at week 8, there was no significant difference among these 3 plasma concentration categories.

This article does not, however, evaluate the impact of differences in time course of plasma concentrations.



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