Final FDA Approval of Sansrosa, expect 15 months post Phase III

Written by on June 15, 2011 in New Rosacea Treatments, Sansrosa with 5 Comments

A popular topic online at the various rosacea forums is to guess when Sansrosa will become available. So far all guesses have proved way way too optimistic.

Given that we believe that the process is in the later stages of Phase III, what sort of best outcome possible, educated guess might be worth offering up?

Once the Phase III process completes (which itself averages 3.5 years) the final FDA approval of a New Drug on average takes around 15 months. This puts a dose of reality for those following drugs like Sansrosa or even further out, V-101.

Our current best guess for completion of Phase III trials for Sansrosa is around August 2012. So even if Galderma are ready to file the 100,000 pages of a New Drug Application at the end of 2012, then don’t expect any approval before the middle of 2014 at the earliest.

Sobering for those waiting.

Mid 2014 is Still Hopeful

There is currently no firm reason to believe that the Phase III trials will successfully complete at the end of 2012, but assuming the best case, for the sake of making an argument, the FDA approval process itself adds another one and half years.

Biopharmaceutical Research Companies Are Developing Nearly 300 Medicines to Treat Diseases of the Skin

New Drug Application (NDA)/Biologic License Application (BLA). Following the completion of all three phases of clinical trials, a company analyzes all of the data and files an NDA or BLA with FDA if the data successfully demonstrate both safety and effectiveness. The applications contain all of the scientific information that the company has gathered.

Applications typically run 100,000 pages or more.

The average review time for the 21 new therapeutics approved by the FDA in 2010 was 14.8 months.

Just one final note of caution: also be sure to factor in Galderma’s own timings and decisions as well. Galderma may possibly decide themselves that the drug isn’t suitable to become a product and halt the development at any time.

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Read more about: New Rosacea Treatments, Sansrosa

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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. Bjask says:

    I see that Sansrosa is supposed to be helpful for people with erythema (facial redness). But most rosaceans also struggle with seborrhea, many with acne and/or seborreich dermatitis, ocular problems etc.

    I find it hard to be so optimistic about Sansrosa when it adresses only one thing: redness.

    Or did I misunderstand something?

    Regards
    Bjask
    Norway

  2. Hi Bjask,

    As the erythema associated with rosacea is the symptom that most poorly addressed by existing treatments, sansrosa showed promise because it was able to treat this redness.

    So far we don’t know what, if any, other benefits might be offered by the final formulation, but officially, it is only for redness.

    davidp.

  3. realist says:

    Sansrosa is not going to be the wonder drug its claimed as brominidine tartrate has been around for decades and was actually the active ingredient in a previous treatment that was discontinued due to relatively no benefit to facial erythema.
    Its just another case of remarketing an ancient drug as in the case of tetracyclines that we are told are new super drugs but are in fact many decades old.
    P.S: Read warren fellows book about his time spent in a thai prison and how tetracycline is used there for almost every illness, if the drug is so good then why is it used in babaric thai prison systems where concern for human welfare is bottom of the list……..

  4. William says:

    Actually, brimonidine tartrate has never been approved for anything other than ophthalmologic use by the FDA, as far as I understand. It has only ever been prescribed as a glaucoma medication.

    That being said, I have to say that I, too, am very bewildered by Sansrosa. On the one hand, it’s incredibly disheartening to read the many reports of rebound flushing submitted by forum members who applied the active ingredient to their faces. It would seem to indicate something naturally problematic with the mechanism of action behind the drug, rendering any attempt to bring it to market totally pointless.

    But then, Galderma couldn’t be that dumb, could it? With the average cost of conducting a Phase 3 trial averaging around $26,000 per patient (source: http://www.lifesciencesworld.com/news/view/11080), it would be foolish to doubt that Galderma really believes it can ultimately bring Sansrosa to market and make serious money with it. And then there’s the fact that most people who experimented with the FDA-approved brimonidine experienced severe rebound within a few weeks of their first application, while Galderma’s Phase 2 trials stretched over a few months and they still gave the greenlight for Phase 3. One would think that if they encountered such a troubling side effect, they certainly would not have committed to an even more long term study.

    Add in the fact that the brimonidine concentration in Alphagan-P can be either .1 or .15%, while the concentration of Sansrosa that Galderma has settled on is a whopping .5%! If anything, shouldn’t that increase the possibility of rebound? If they’ve settled on such a high concentration, they’ve either solved that problem or somehow remain oblivious. I’d really prefer the former, personally, but who knows.

  5. Dukecity says:

    William, very good points – we’ll know when/if it get’s released, I pray it’s the topical that everyone has been waiting for and that is works well with no rebound.

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