Sansrosa starts Phase 3 Trials (again)

Written by on March 20, 2011 in Galderma, New Rosacea Treatments, Sansrosa with 9 Comments

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News today that Galderma has listed CD07805/47 as entering large scale Phase III trials. Under the previous owners of the Brimonidine-based technology Collagenex, the product then known as Sansrosa was previously slated to commence Phase 3 Trials at the end of 2008.

The last news we heard about this product was in August last year when Galderma announced that they were restarting Phase II trials to examine the optimum dosage of the active ingredient. The Phase III trials have now chosen a concentration of 0.5% for the product moving forward.

We have no information about what caused Galderma to send the development of Sansrosa backwards, but it is encouraging to see the product finally moving forward again.

Why So Slow?

Reinforcing how slowly a new drug moves through the development pipeline are the dates for this study. This study just announced today won’t complete until August 2012. Naturally if you want to claim that a drug is safe to use for a year, you need to trial it for at least that period.

Experimenters Beware

Given that the one possible listing of ingredients of this product are known, you may be tempted to try it on your own. Please be careful, feedback from adhoc experiments is not positive with many reporting bad reactions including rebound redness.

Trial Details

Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Drug: CD07805/47 gel 0.5%

To evaluate and document the long term efficacy & safety of CD07805/47 gel 0.5% in subjects with moderate to severe facial erythema associated with rosacea.

Estimated Enrolment: 450

Study Start Date: March 2011

Estimated Study Completion Date: August 2012

Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

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

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9 Reader Comments

  1. Tom says:

    This is positive news. After the last couple of updates I was confident the new drug would be abandoned.

  2. j says:

    Is it likely to be released immediately following a successful phase 3 trial?

  3. If, and only if everything is satisfactory to Galderma at the end of the trials will they submit it to the FDA.

    If and only if the FDA are happy will they approve it as they find it.

    My advice would be don’t count on this happening less than a year from the end of Phase III.

  4. Mark Evans says:

    I have tried this topical in the form of the eye drops, I get terrible rebound flushing… I think the time release liposomes must be the key here…If the ingriedient is slowly released over a 24 hour period I could see it working beautifully.

  5. Hi Mark,

    So far it is only speculation that there is a time release component in the Sansrosa Topical. Certainly Galderma haven’t mentioned this as being a part of the product.

    I’m in two minds whether this could be a reason that the formulation being trialled is supposedly safer than Alphagan eye drops.

    It is equally plausible to me that there are probably enough irritants in the eye drops that once you remove those, a gentler formulation performs better.

    Either way we probably won’t know for quite a while yet what it really contains.

    davidp.

  6. Also wanted to also add that a 24 hour release for a topical is impossible and even such a long release period for a systemic therapy is also technically implausible. A few hours through the stomach and large intestine OK, but on the skin no way.

    Just wanted to temper any hope in something just seems very unlikely to me.

  7. Just to followup on dates, on average, the FDA takes around 15 months to approve a New Drug Application. So even if Galderma are ready to file the 100,000 pages of a NDA at the end of 2012, then don’t expect any approval before the middle of 2014 at the earliest.

  8. George says:

    There is a member on another forum who was involved in the phase 3 trials for sansrosa. He experienced major rebound redness exactly the same as people who have tried to use the alphagen (eyedrop) form of this product.

    I cant believe that Galderma have continued to try and push this product to phase 3 when it is obviously floored. This has been the main hope for a product that actulally works for a condition that affects millions of people. I have personally been following for a long time and feel very dissapointed this is the best the companies have been able to come up with in this age of tecnology we live in.

  9. Hi George,

    I wouldn’t put too much weight on anecdotal reports from sources that we can’t verify for eg.

    The job of the blind trials is to eliminate conscious and unconscious bias both for and against the product and dis/prove that it works and is safe for the population at large. Thus at the end we will have a genuine idea of whether it works or not.

    The rate of progress is slow, but getting a new drug approved is a very slow and very expensive process. I wrote some recent posts on just how slow and expensive it really is, and indeed how many drugs fail along the way.

    davidp.

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