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Integrated Review of Efficacy A.Brief Statement of Conclusions The efficacy of alprazolam XR (XANAX XR) in the treatment of Panic Disorder was demonstrated in one 6-week, randomized, double-blind, placebo-controlled, multicenter trial in which the drug was dosed once-daily. Treatment with the drug resulted in statistically and clinically significant reductions in the number and severity of panic attacks, phobic avoidance, and in global measures of the severity of illness and dysfunction associated with the illness.
B.General Approach to the Review of Efficacy Study M/2000/036S* was reviewed for efficacy, as it has been designated as the pivotal placebo-controlled efficacy trial. The other 4 placebo-controlled studies, for which data had been submitted, were briefly reviewed for efficacy analyses. Furthermore, the Division had previously made the decision that one positive pivotal trial was adequate to establish efficacy.
DSI investigated all 3 sites and found that complete data were not available at one of the sites. Thus, the adipex hoodia hydrocodone meridia phentermine Division performed 2 separate efficacy analyses, one using data from all 3 sites and one using data from the 2 sites in which complete data were available.
' C.Detailed Review of the Pivotal Trial, M/2000/0369 C-l Investigators and Sites Refer to the Appendix (Section XI.A.) C-2 Objectives The primary objective of the study is to compare the efficacy and safety of XANAX XR with that of placebo in the treatment of > Panic 20 buy xanax Disorder with or without Agoraphobia. Pivotal Trial Reviewed for the Analysis of Efficacy Placebo-Controlled Study (M/2000/0369) of Alprazolam XR in Panic Disorder Study Number Study Design Duration Treatment Regimen ITT: # of Patients M/2000/0369 hydrocodone recommended dosage Reviewed for efficacy & safety Randomized, D-B, P-C, Flexible Dose 6 weeks of treatment; 5 wk Discontinuation XANAX XR 1-10 mg QD 104 Placebo QD 96 C-4 Study Population Enrolled subjects were male and female outpatients, between the ages of 18 and 65, who had a diagnosis of Panic Disorder with or without Agoraphobia (as defined by DSM-III), with limited or extensive phobic avoidance.
For details regarding subject inclusion and exclusion criteria, refer to the Appendix (Section XI.B.). The inclusion and exclusion criteria are appropriate. C-5 Baseline Demographics and Severity of Illness Baseline Demographics for Study 0369 ITT Population Variable XANAX XR Placebo Age (yrs) n=104 n=95 Mean 35.0 34.8 p-value 0.855 Sex, No. (%) pts S II a n=95 Male 43 (41) 36 (38) Female 61 (59) 59 (62) p-value 0.619 Race, No. (%) pts n=104 n=95 White 99 (95) 92 (97) Black 3(3) 2(2) Hispanic 1(1) 1(1) Oriental 0(0) 0(0) American Indian 0(0) 0(0) Other 1(1) 0(0) p-value - 0.789 Weight Gbs) /, n=99 n=94 Mean 162.3 158.adipex hoodia hydrocodone meridia phentermine 8 p-value 0:519 History of men ial illness, No. (%) pts % o n=95 Yes 9(9) KD p-value 0.014 Baseline adipex hoodia hydrocodone meridia phentermine Severity of Illness in Intent-to-Treat Population Primary Efficacy Parameters at Baseline XANAX XR (N=104) Placebo (N=95) P-value Total Panic Attack Mean (SD) 6.27 (6.14) N=104 5.99 (5.57) N=95 0.82 Overall Phobia State Mean (SD) 6.89 (2.adipex hoodia hydrocodone meridia phentermine 29) N=102 6.95(1.99) N=93 0.81 Clinician's Global Impression: Severity of Illness Mean (SD) 4.54 (0.83) N=103 4.41(0.94) N=95 0.45 C-6 Study Design The study was a randomized, double-blind, placebo-controlled, adjustable dose, three- center study. Subsequently, there was a 5-week adipex hoodia hydrocodone meridia phentermine phase for monitoring of drug discontinuation and injecting tramadol withdrawal phenomena. Dosing of alprazolam ranged from 1-10 mg once daily. The study included the following phases: (a) a screening visit; (b) a one-week drug-free run-in period; (c) a 6-week double-blind treatment period in which dosing could be adjusted to a maximum of 10 mg per day, based on response and tolerability; (d) a medication tapering period of up to five weeks until no medication was administrated; and (e) a post- discontinuation evaluation period in which subjects returned two weeks after discontinuation of medications. Medication was administered once daily in the moming. Dosing was initiated at 1 mg/day, and doses were not to exceed 10 mg/day for a total of 6 weeks.
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