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Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientific Meeting
Date:10/29/2009

on were pooled by dose across all one-year studies in an effort to provide a more accurate estimation of the incidence of each event. This pooled analysis, presented in September, which is a part of the Integrated Summary of Safety (ISS) in the Qnexa NDA, demonstrates that the discontinuation rates for these various cognitive-related events were low and all occurred at a frequency of less than 1%. Specifically, the discontinuation rates from the ISS due to cognitive events from the year-long Qnexa studies (OB-302, OB-303 and OB-202/DM-230) were:


    MedDRA Preferred Terms             Qnexa    Qnexa    Qnexa    Qnexa All
                            Placebo     Low      Mid      Full     doses
                           (n=1,561)  (n=240)  (n=498) (n=1,580)  (n=2,318)
                            -------    -----    -----   -------    -------
    Disturbance in
     Attention               0.2%       0.0%     0.0%     0.9%       0.6%
    Memory Impairment        0.1%       0.0%     0.0%     0.3%       0.2%
    Amnesia (forgetfulness)  0.1%       0.0%     0.2%     0.4%       0.3%
    Aphasia (word finding
     difficulties)           0.0%       0.0%     0.0%     0.3%       0.2%
    Cognitive Disorder       0.1%       0.0%     0.0%     0.1%       0.1%
    Confusional State        0.1%       0.4%     0.2%     0.1%       0.2%
    Bradyphrenia (slow
     thinking)               0.0%       0.0%     0.0%     0.1%       0.0%
    Disorientation           0.0%       0.0%     0.0%     0.0%       0.0%
    Mental Impairment        0.0%       0.0%     0.0%     0.0%       0.0%

    Events are not additive as some patients have reported more than one
    event leading to study drug discontinuation

Of the events shown in the table above, the most frequent reason for patients discontinuing Qnexa was disturbance in attention. For the 1,580 patients receiving full dose Qnexa, the discontinuation rate for this event was 0.9%. This rate is considerably lower
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SOURCE VIVUS, Inc.
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