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In neither of these studies could the alprazolam dose be used to predict the treatment for an individual patient. 4.4.3 Tolerance 4.4.3.1 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) com order quinton site xanax 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 3.3.2.1) 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 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). The mean maximum sedation scores for the 8 and 10 mg doses were similar to that observed for the 6 mg doses (R/2002/003). Chronic tolerance appeared to develop with multiple dosing of IR tablet (P/2002/0010; R/2002/0002) and XR tablet (M/2000/0253; P/2002/0010; R/2002/0002). •The peak sedation score for the 3 - and 6-mg treatments during the multiple dose administration (steady-state) com order quinton site xanax were significantly lower than the peak sedation scores after single dose administration. The peak sedation during the com order quinton site xanax multiple dose administration of XR (1, 3, or 6mg) was; not different among treatments even though there was a 6-fold difference in dose (M/2000/0253). •After 7 days of multiple dosing (XR 3mg bid, IR 1.5mg qid), subjects developed chronic tolerance to the sedative effect (P/2002/0010). Similar results were observed after 6 days of multiple dosing (XR 6mg qd, IR 1.5mg qid), although the extent of tolerance was not complete for the XR tablet treatment (R/2002/0002). •Tolerance develops rapidly and to the same extent after multiple dosing from either dosage forms in healthy volunteers |XR 6mg/day (qd or bid); IR 1.5mg qid]. 4.4.4 Pharmacodynamics (Safety/efficacy) of XR tablet 4.4.4.1 Does the slow release rate of XR tablet have an effect on the pharmacodynamics (Safety/efficacy) of the compound? (Hossain's review; Pharmacometrics review: Mishina) 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 com order quinton site xanax bid, 6mg qd) fonnulation are similar, the conclusion of the same efficacy and safety of both formulations may be controversial. The results were inconsistent when comparing across the IR and XR tablet treatment groups in clinical trials. Note: all the clinical studies were carried out in once daily dose. (1)In the treatment phase: the premature treatment discontinuation in treatment phase was more associated with XR group (28%) than the IR group (10%). The main reason for that was the occurrence of medical events (XR: 16.6% versus IR 4.3%). [M/2000/0271, M/2000/0369, M/20002/0002], M/2002/0003].



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