Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientif...(on were pooled by dose across all one-ye...),Health

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
'/>"/>

SOURCE VIVUS, Inc. Copyright©2009 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8
Related medicine technology :

1. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
2. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
3. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
4. PTC Therapeutics Announces Additional Results from Phase 2 Study of PTC124 in Duchenne Muscular Dystrophy
5. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
6. Coley Pharmaceutical Group and Pfizer Nominate Additional Anti-Cancer Compound for Clinical Development
7. Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
8. Pharmacopeia Announces Additional Positive Findings from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
9. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
10. Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
11. Paul Capital Healthcare Purchases Additional Royalty Interest in GlaxoSmithKlines Rotarix(R)