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However, these analyses were not performed for the following reasons: (1) analytical data for alprazolam at the assay labs used for these analyses were not of the quality contained in the balance of the application, (2) the population pharmacokinetics of alprazolam have previously been published, (3) the population pharmacodynamics of alprazolam have been described, and (4) population analysis of pharmacokinetic data from Phase I studies with alprazolam XR tablets have been described ( Hossain et al). Consequently, the evaluation of exposure-response with clinical endpoints for XR tablet was not hydrocodone use why feasible. The sponsor requested a deferral of pediatric studies. At the pre-NDA meeting for Xanax XR under IND23; 179 dated July 19,2001,. ._ _ Eighteen of the 23 studies submitted to the Clinical Pharmacology and Biopharmaceutics were previously submined in 1991 - - " ./and reviewed by Dr. Comments from OCPB were sent to the sponsor before the sponsor; , Summarized below are the studies reviewed by Hossain: • Pharmacokinetics hydrocodone use why after single doses & repeated doses of alprazolam XR . - • Relative bioavailability (0.5, 1, 2, 3mg) • Dose black cohosh and hydrocodone proportionality (1-1 hydrocodone use why Omg) • Dose strength equivalency (0.5, 1, 2, 3mg) • Food study •Manufacturing site change: BE study of highest strength • in vitro dissolution methods and specifications • Bioanalytical assay validation Following are the 5 new studies with XR product submitted in current submission: PK of XR product relative to meal timing (P/2002/0017), abuse liability (P/2002/0008), PK/PD in healthy volunteers [(M/2002/0020 (proof of concept), M/2002/037, M/2002/0044)]. PK data from the latter two studies were neither provided nor analyzed by the sponsor. Based on the new data submitted and the clinical relevance of the PD measures, following studies/topics were reviewed by current reviewer: • PK of XR tablet relative to meal timing •Literature-based diug-drug interaction information •Literature-based population PK in healthy volunteers. -- dosing: pivotal efficacy trial was carried out with once daily dosing. •in vitro dissolution methods and specifications were reviewed since the sponsor provided some justification for choosing the proposed dissolution specifications and method over the one that was agreed upon between the Agency and the sponsor in this regard ' ~ •Dissolution profile c omparisons for three lower strengths between batches manufactured at old and new sites: All the batches used in clinical and biopharmaceutical studies were manufactured at the old site without debossing. BE was demonstrated in the highest strength (3mg) made from both sites. •Dissolution profile comparisons regarding debossing issues for the final-to-be marketed formulation: neither clinical nor biopharmaceutical studies were conducted using to-be-marketed 2-sided debossed tablet.

In summary, following information were not reviewed: •Proposed pediatric development plan: These protocols will be reviewed when the Clinical Division makes a decision whether or not to grant the deferral of pediatrics studies •IVIVC: The sponsor had indicated during the teleconference (03/22/2002) hydrocodone use why that since the IVIVC development was hydrocodone use why not successful, they are not using IVIVC to help set dissolution specifications and has . Therefore, requested individual data were not provided by the sponsor. •Abuse liability (P/2002/0008), PK/PD in healthy volunteers [(M/2002/0020 (proof of concept), M/2002/037, M/2002/0044)].

Data from the latter two studies were neither provided nor analyzed by the sponsor.



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