Managed Care - November 2008 - (Page 29)

IMPORTANT CORRECTION OF DRUG INFORMATION ABOUT EFFEXOR XR® (VENLAFAXINE HCI) EXTENDED-RELEASE CAPSULES An advertisement in professional journal publications for EFFEXOR XR® (venlafaxine HCI) Extended-Release Capsules for the treatment of major depressive disorder was the subject of a Warning Letter issued by the U.S. Food and Drug Administration (FDA) in December 2007. The FDA stated that the journal ad was misleading because it overstated the efficacy of EFFEXOR XR, made unsubstantiated superiority claims, and contained other unsubstantiated claims regarding EFFEXOR XR. Wyeth would like to take this opportunity to clarify the content of the advertisement. Claims that Reference the Baldomero et al Study and Other Related Claims The FDA objected to the claim, “In an open-label study of patients who failed previous antidepressant treatment, nearly 60% achieved remission when changed to EFFEXOR XR.” The FDA determined that the Baldomero study (the cited reference for this claim) could not be relied upon as substantial evidence to support the claim due to the following reasons: (1) the study was an openlabel study, which is not an appropriate study design to measure subjective end points because it fails to minimize potential bias; (2) the study did not include a placebo group, so there was no way to determine the actual effect size of the drug; and (3) the study did not provide information about whether EFFEXOR XR was superior to failed therapy because study subjects were not randomized to their previously failed therapy. Therefore, the FDA stated that the study failed to support the 60% remission rate claim as well as any conclusion that EFFEXOR XR is superior to other antidepressant treatments. In addition to the above claim, the FDA stated that other claims added to the misleading impression that patients who have failed previous antidepressant therapy can expect improvement when switching to EFFEXOR XR. Claims from the PREVENT Study The FDA objected to the claim, “In the PREVENT study, the probability of preventing a new episode of depression was 92% with EFFEXOR XR in maintenance year 2 vs. 55% with placebo.” The FDA stated that the cited claim overstated the efficacy of EFFEXOR XR by implying that the general patient population suffering from major depressive disorder can expect a 92% probability of preventing a recurrent depressive episode after two years of treatment when this is not supported by substantial evidence. The cited study for this claim was a randomized, multicenter, double-blind study (n=1096) comparing EFFEXOR XR with placebo. The study was designed to provide efficacy data regarding recurrence prevention with EFFEXOR XR after two years of maintenance treatment. It followed patients through 4 different time periods: a 10-week acute period, a 6-month continuation period, an initial 12-month maintenance period (maintenance year 1), and a second 12-month maintenance period (maintenance year 2). At the end of each period, patients were only considered eligible for inclusion in the next period if they were still responding to the drug. Patients dropped out of the study during each of the periods for different reasons (eg, lack of efficacy, adverse events). At the start of each maintenance period, the remaining patients who still showed a response to EFFEXOR XR were re-randomized to EFFEXOR XR or placebo. Because a high percentage of EFFEXOR XR patients were either re-randomized to placebo or were discontinued from the study before entering maintenance year 2 and because only patients who responded to EFFEXOR XR were selected to continue to the next phase of treatment, the FDA determined that the results of the study could not be extrapolated to the general patient population suffering from major depressive disorder. Claim Regarding Clinical Experience and Number of Patients The FDA objected to the claim, “More than 12 years of clinical experience and over 20 million patients treated with EFFEXOR/EFFEXOR XR.” The claim of 20 million EFFEXOR/EFFEXOR XR patients was estimated from the number of U.S. prescriptions, average daily consumption, and average length of therapy. The FDA determined that this claim was misleading based on the referenced data because the calculations used did not reflect the number of “unique” patients. Because there are no unique patient-level data available for the entire 14-year period during which EFFEXOR/EFFEXOR XR has been on the U.S. market, the claim is no longer used in EFFEXOR XR promotional materials. Please see brief summary of Prescribing Information on adjacent pages. EFFEXOR® and EFFEXOR XR® are registered trademarks of Wyeth Pharmaceuticals Inc. © 2008, Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101 231275-01 August 2008

Table of Contents Feed for the Digital Edition of Managed Care - November 2008

Managed Care - November 2008 Editor’s Memo Contents News and Commentary Legislation & Regulation Letters Medication Management Compensation Monitor Do It Yourself for Less Biomarkers Promise, but Do They Deliver? Oncologists Complain About Drug Payment Consider Blood Pressure Self-Monitoring Q&A: Keep Industry in the Game Formulary Files Plan Watch Tomorrow’s Medicine Outlook Respiratory Syncytial Virus Managed Care Considerations Contents Continuing Education Objectives RSV Disease in the Pediatric Population In the Trenches RSV Infection in the Adult Population Health Plan Medical Director Health Plan Pharmacy Director RSV Issues and Solutions Assessment/Evaluation/Certificate Request Post-Test

Managed Care - November 2008

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