ClinicalTrials.gov lists this study of Saphris® (asenapine) as completed in December 2007. It is now almost April 2010. The study showed no difference -- over a placebo -- at 52 weeks. It was never published, until this past week, in Munich, apparently. Background here, from Salmon. As you can readily see, no study results are indicated as published, at ClinicalTrials.gov, for this study -- as I type this:
. . . .No Study Results Posted on ClinicalTrials.gov for this Study. . . .
Why is that? And why is it that the report out, in Munich last week, unduly highlighted only three week data (offering the misleading impression that the study turned out favorably, for asenapine), despite the title of the study indicating a "12 weeks, plus 40 weeks" duration? Per Salmon:
. . . .In summary there was an initial study that looked at efficacy at three weeks in patients who were taking Lithium or valproate (possibly relapsed). The responders were then continued to 12 weeks and then 52 weeks (12 + 40). [There was efficacy shown at three weeks, at just the duration for which FDA has approved asenapine. . . .] However, beyond three weeks, it appears there is likely no efficacy. All of this, in spite of the primary endpoint being at three weeks Merck titles the abstract "[Presentation title: Asenapine as Adjunctive Treatment for Bipolar Mania: A Placebo-Controlled 12-Week Study and 40-Week Extension. Abstract PW01-28]". . . .
March 25, 2010 @ 11:57 AM
We should start asking after these questions. Do the press people sitting in Whitehouse Station have answers? The study involved fewer than 170 patients -- how on Earth did it take almost two and one-half years to make public mention of the data?
[ENHANCE much, anyone? Anyone. . . . anyone?]