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Comment: Drs.Levin and Kong considered this a supportive study, but not a positive study, and I agree.

Given that neither active drug was shown to be superior to placebo, I consider this a failed study that does not need to be described in labeling. 5.1.3Summary cheap hydrocodone online of Study M/2002/0003 This was a randomized, double-blind, parallel group, 8-week, fixed-dose, multicenter (16 US sites) study comparing Xanax XR, at doses of 4 and 6 mg/day, on a qd schedule, and placebo, in adult outpatients (18-65) meeting DSM-III criteria for panic disorder, with or without agoraphobia.

There were 5 primary endpoints: change from baseline in total number of panic attacks'; proportions of patients with zero panic attacks at endpoint; change from baseline in CGI-S; CGI-I; and change from baseline in Overall Phobia State. The ITT population included roughly 90 patients per group. The results of this study we:re uniformly negative, for both dose groups, and for all 5 primary endpoints. Levin and Kong considered this a negative, and I agree. 5.1.3Summary of Study M/2002/0002 This was a randomized, double-blind, parallel group, 8-week, fixed-dose, multicenter (15 US cheap hydrocodone online sites) study comparing Xan;ix XR, at doses of: 4 and 6 mg/day, on a qd schedule, and placebo, in adult outpatients (18-65) meeting DSM-III criteria for panic disorder, with or without agoraphobia. There were 5 primary endpoints: change from baseline in total number of panic attacks; proportions of patients with zero panic attacks at endpoint; change from baseline in CGI-S; CG1-I; and change from baseline in Overall Phobia State. The ITT population included roughly 75 patients per group. The results of this study were uniformly negative, for both dose groups, and for all 5 primary endpoints.

Levin and Kong considered this a negative, hydrocodone online without rx and I agree. 5.1.4Comment on Other Important Clinical Issues Evidence Bearing on the Question of Dose/Response for Efficacy There were no data in this program that contribute useful information to the question of dose response for effectiveness. Labeling will simply describe how patients were dosed in the one positive trial. Clinical Predictors of Response Exploratory analyses were done to detect subgroup interactions on the basis of gender, and these analyses suggested treatment effects in both strata.

Size of Treatment Effect The effect size as measured by difference between drug and placebo in change from baseline on the 7 primary' endpoints in study 369 was similar to that seen in the positive trials for other drags approved for panic disorder. I consider this a sufficient effect to support hydrocodone picture of narcotic painkillers a claim for this product in panic disorder. Duration of Treatment There were no data presented in this program pertinent to the question of the longer-term efficacy of Xanax XR in panic disorder. 5.1.4Conclusions ELegarding Efficacy Data The sponsor has, in my view, provided sufficient evidence to support the claim of short-term efficacy for Xanax XR in panic disorder. Levin's safety review of this NDA was based predominantly on the safety data from the 5 placebo-controlled studies conducted in patients with panic disorder for this program. There were n=531 panic disorder patients exposed to Xanax XR across these 5 studies, representing about 62 patient years of exposure. The majority of patients treated with Xanax XR in these trials (81%) received mean daily doses in a range of 2 to 6 mg.

Any SAEs were also examined from the entire Xanax XR exposed-population in this NDA, i.e., a buy oxycodone without prescription total of n=1564. These exposures came from a total of 24 phase 1 studies (n=598 Xanax XR exposures) and 13 phase 2-3 studies (n=966 Xanax XR exposures). There were no deaths in this development program Given our prior knowledge ofthe risks associated with Xanax IR in the two populations for which this drug is approved, the focus in the safety review was on any differences between the. recognized safety profile with the IR formulation with that cheap hydrocodone online observed for Xanax XR in patients with panic disorder. 5.2.1Overview of Adverse Event Profile for Xanax XR in Panic cheap hydrocodone online Disorder Overall, die adverse events profile for Xanax XR in the panic disorder population was similar to that observed for Xanax IR.



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