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New Long-Term Data on QNEXA® Show Significant and Sustained Weight Loss of Greater Than 10% Over Two Years
Date:9/21/2010

500 calories per day.

Specific SEQUEL findings include the following primary endpoints:

  • Patients taking top- and mid-dose QNEXA achieved and maintained weight loss over two years of 11.4% and 10.4% of their initial body weight, respectively, as compared to placebo-treated patients with 2.5% weight loss (ITT-LOCF, p<0.0001).
  • A majority of all patients taking QNEXA exceeded 10% weight loss, the goal established by the National Institutes of Health (NIH) to decrease the severity of obesity-associated risk factors.
  • The percentage of patients achieving categorical weight loss of at least 5%, 10% and 15% on both QNEXA doses was statistically significant compared to placebo:

  • Categorical Weight Loss (ITT-LOCF)

    5%

    10%

    15%Top-dose

    79%*

    54%*

    32%*Mid-dose

    75%*

    50%*

    24%*Placebo

    30%

    12%

    7%*p<0.0001 vs placeboAverage weight loss over two years of therapy with QNEXA from the SEQUEL study is depicted in the following graph:

    (Photo:  http://photos.prnewswire.com/prnh/20100921/CG67932)

    (Photo:  http://www.newscom.com/cgi-bin/prnh/20100921/CG67932)

    Treatment-emergent serious adverse event rates in SEQUEL were low (top-dose = 4.1%; mid-dose = 2.6%) and similar to placebo (4.0%), with no drug-related serious adverse events reported.

    The completion rate in SEQUEL was approximately 83% for both QNEXA doses and 86% for the placebo group. Discontinuations due to adverse events were 3.9% and 4.1% for the mid- and top-dose, respectively; and 2.6% for the placebo group; with no single adverse event leading to discontinuation in more than 1% of patients.

    Additionally, SEQUEL data confirms previous safety findings, with no evidence of suicidality and no reports of suicidal attempts or behav
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    SOURCE VIVUS, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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