Sansrosa Completes Phase III Trials

Written by on March 16, 2012 in Galderma, Red Face of Rosacea, Sansrosa with 5 Comments

A short press release today from Galderma to say that the 2 Phase III trials for Sansrosa have completed successfully.

These latest large scale trials were able to confirm the positive findings resulting from the Phase II trials.

This must be a great relief to Galderma who had to return to Phase II trials after previously commencing Phase III trials.

March 16, 2012 08:00 ET

Galderma Announces Completion of Phase 3 Trials of Investigational Drug Targeting Facial Erythema of Rosacea

FORT WORTH, TX–(Marketwire – Mar 16, 2012) – Galderma Laboratories, L.P. today announced the completion of two independent Phase 3 clinical trials that evaluated the efficacy and safety of CD07805/47, a proprietary topical gel under investigation in adults with moderate to severe facial erythema (redness) of rosacea. Rosacea is a chronic, inflammatory and vascular condition of the face and eyes characterized by persistent erythema, flushing, inflammatory lesions and visible blood vessels that affects at least 16 million Americans and with estimates of prevalence ranging from less than 1% to more than 20% of the adult population in other countries globally.

The results of the two randomized, vehicle-controlled, multicenter Phase 3 trials that investigated the efficacy and safety of CD07805/47 applied topically once daily vs. vehicle (control) in adult patients with moderate to severe facial erythema of rosacea confirmed results observed in prior Phase 2 studies.

Galderma intends to submit a New Drug Application for CD07805/47 to the U.S. Food & Drug Administration and to the European Medicines Agency.

When Will Sansrosa Be Available?

Best answer: No ones knows. There are just too many things still to be decided. It may never even get to market. My guess at the earliest you might see Sansrosa available is mid 2014. I reserve the right to push this date out at any time :) and please note that mid 2014 is still a pretty hopeful date.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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5 Reader Comments

  1. Dukecity says:

    THX David,
    Should be a big help to a lot of people with rosacea out there..

  2. Joyce Tracy says:

    Has it been tested on anyone with severe rhinophyma??? My husband would be a very good candidate for testing.

    Please advise,
    Joyce Tracy

  3. David Pascoe says:

    Hi Joyce,

    Sansrosa (more correctly called CDCD07805/47 while in development) has only been evaluated for the redness associated with facial rosacea.

    davidp.

  4. James Walker says:

    David,

    Since Sansrosa won’t be available the earliest 2014, how abut us rosacea suffers using Brimonidine Tartrate or glaucoma gel that has brimonidine in it.

    Thank you,

    James Walker

  5. David Pascoe says:

    Hi James,

    Several people have tried to use Alphagan P but it hasn’t ended well – Sansrosa delayed, sufferers make their own Brimonidine, BEWARE. Everyone is hoping that the final formulation of Sansrosa is as good as the trials suggest because Alphagan P is not a good option.

    davidp.

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