Auxilium reports trial results for cellulite product candidate


Auxilium Pharmaceuticals (NASDAQ:AUXL) announces the results from a Phase 2a clinical trial evaluating the safety and efficacy of injections of collagenase clostridium histolyticum (CCH) for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Three doses (low-0.06mg; mid-0.48mg; high-0.84mg) of CCH showed an improvement in the appearance of cellulite as measured by investigator- and patient-generated scores on the Global Aesthetic Improvement Scale (GAIS).

The mid and high dose groups demonstrated a statistically significant improvement in the appearance of cellulite (measured by GAIS scores) with a p-value of <0.05. In these two groups, 68% of patients rated themselves "satisfied" or "very satisfied" with the results compared to 34% in the placebo cohort.

Dulling the veneer of the results is the fact that the trial is based on subjective observational data, as evidenced by the 34% satisfied/very satisfied proportion of the control group. The results would be more robust if the reduction in cellulite was independently quantified. Also, the p-value, ideally, would be <0.01 or less.

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Comments (2)
  • rambler1
    , contributor
    Comments (1048) | Send Message
     
    If your not a scientist, genius or analyst what the heck does that mean?
    21 Aug 2014, 09:29 AM Reply Like
  • stk28097
    , contributor
    Comments (311) | Send Message
     
    It means that 68% of the patients that recieved the drug were "Satisfied or Very Satisfied" with the results. Which is a very good thing for the stock. However, 34% of the patients who did not get the drug said the same thing. This makes the results from the drug group not as strong. Also the P-value of <0.05 is not as good as <0.01 which would be great. The P-value indicating the statstical signifigance. All in all This is positive data for the company. I think if this drug gets approved for ceullite it would be very popular not quite botox popular but still it could be a home run for them.
    21 Aug 2014, 10:00 AM Reply Like
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