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The sponsor did not properly investigate the PK/PD relationship in the target patient population using clinically relevant endpoint(s) for XR tablet. Specifically, the sponsor conducted several studies (both single dose and multiple: doses) to evaluate PK/PD of alprazolam XR and IR tablets.

Unfortunately, these studies can not be interpreted meaningfully for the following reasons: (1) Studies did not include control group. (2) Only healthy volunteers were enrolled in the studies to evaluate the relationship between alprazolam plasma concentrations and side effects (psychomotor performance and sedation). (3)Psychomotor performance was evaluated with the digital symbol substitution test (DSST)and avaloungenyc com new tramadol tramadol card sorting tasks after single and multiple doses.

The psychomotor performance was neither measured in clinical studies nor cod tramadol money orders correlated with the clinical efficacy or safety measures.

The sponsor attempted to explore the exposure-response relationship and cod tramadol money orders blood samples were collected in 2 cod tramadol money orders efficacy trials (M/2002/0369 & M/200/0271). However, the sponsor did not provide PK data or PK & PK/PD analysis because of the following reasons: (1) the concerns in quality of lab measures, (2) Population PD of IR had been evaluated, (3) Pop PK of XR had been described.

As a result, the exploration of exposure-response was not feasible. For Xanax IR, on the oilier hand, the sponsor had investigated the dose- or concentration-response relationship in two of the efficacy trials and results indicated that the efficacy of Alprazolam IR tablets in the myspacesafetytips com phe phentermine cod tramadol money orders treatment of panic disorder has been established. Briefly, the results from study #4432 demonstrated that patient response, based on the reduction of major panic attacks, was related to alprazolam plasma concentrations determined at steady-state at doses of 2 and 6 mg/day of alprazolam IR tablets in these patients. However, it should be noted that the sponsor indicated in the current submission, "the clinical summary section", that results from analyses from #4432 and another trial difference between lortab and oxycontin #4412 (a short-term study with IR tablet) did not establish a minimum effective alprazolam dose cod tramadol money orders or levels or window of effective doses or levels. In neither of these studies could the alprazolam dose be used to predict the treatment for an individual patient.

4.4.3 Tolerance Has tolerance developed from alprazolam treatment? (Hossain's review: M/2000/0253, R/2002/003, P/2002/0010; R/2002/0002) Yes, tolerance (both acute and chronic) to the psychomotor function (digital symbol substitution score test =DSST) and sedative effects has been observed from alprazolam treatment in healthy subjects. This phenomenon is independent of route of administration or formulation (iv, IR, XR) or dose (IR 1.5 mg ; XR, 1, 3, 4, 6, 8 or lOmg). The sponsor indicated that tolerance in psychomotor function was suggested when "clockwise" hysteresis was observed when mean percent decrement in DSST was plotted versus the mean log alprazolam concentration. However, psychomotor function measure will not be discussed further since this measure were not evaluated in the clinical trial, or correlated with clinically relevant outcomes, (see section Acute tolerance developed after single doses of XR tablet.

Specifically, the maximal sedation occurred .at approximately 2-3 hours, is independent of dose (XR, po, 1, 3,4, 6, 8 or lOmg), formulation (iv, IR, XR), dosing regimen [XR 6mg/day (qd, bid); IR 1.5mg, qid)] or route of administration [iv lmg; p.o.(IR, XR)] Peak sedative effects were related over the counter hydrocodone china to the XR dose following single dose administration of 1, 3, or 6mg (the degree of sedation increased with dose), but acute tolerance to the sedative effects occurred at later times following the dose (M/2000/0253).

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