Sansrosa not Susceptible to Tolerance or Rebound

Written by on October 20, 2011 in Galderma, Mirvaso Gel (Brimonidine 0.33%), Sansrosa with 2 Comments

Some news today from the Phase 2B Sansrosa Trials;

Galderma is now confirming that during the 8 week trial, participants did not suffer from tachyphylaxis or rebound.

This means that if you stop and start sanrosa or continue to use it for an extended period you likely won’t suffer from a rebound effect or from a reduced effectiveness.

This is some good news as it indicates the formulation remains effective and safe for periods of around 4-8 weeks.

The trial news announced today does not relate to the on going Phase 3 Sansrosa trials.

The trials mentioned in today’s press release were first highlighted in August 2010 – Galderma sends Sansrosa backwards – Phase 2 Dosage Trials Again

PRESS RELEASE Oct. 20, 2011, 2:30 a.m. ED

Galderma Announces Positive Phase 2b Results for Investigational Compound Targeting Redness of Rosacea

LAUSANNE, SWITZERLAND, Oct 20, 2011 (MARKETWIRE via COMTEX)

Galderma Pharma, S.A., today announced positive top-line results from a Phase 2b trial that evaluated the efficacy and safety of CD07805/47, a proprietary topical gel under investigation for treating patients with moderate to severe facial erythema (redness) of rosacea. Rosacea is a chronic dermatological condition of the face and eyes characterized by persistent redness, flushing, inflammatory lesions and visible blood vessels that affects at least 16 million Americans.

“Currently, there are no medical therapies with FDA approval to treat the persistent facial redness of rosacea,” said Joseph F. Fowler, M.D., Clinical Professor of Dermatology at the University of Louisville and a principal study investigator. “The results of this study confirm CD07805/47’s potential to become a viable topical treatment option that could possibly help enhance the quality of life for the millions of patients affected by the persistent facial redness of rosacea.”

In the trial, CD07805/47 was shown to be rapidly effective at reducing facial redness. During the treatment and follow-up phases through the eight-week study, CD07805/47 was evaluated as safe and well-tolerated. There was no evidence of tachyphylaxis, or rebound, in the study.

The results will be submitted for publication where further data and analysis will be provided.

Phase 3 studies are currently ongoing.

Update: Journal Article Publised

The Sansrosa/Brimonidine tartrate (BT) Phase II trial data has also been written up as a Br J Dermatol article. The press release quoted above was a preview of this formal writeup of the Phase II Trials.

We can see that Galderma is working towards recommending the Sansrosa dosage of a 0.5% Gel used once per day.

Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies

Br J Dermatol. 2011 Nov 2., Fowler J, Jarratt M, Moore A, Meadows K, Pollack A, Steinhoff M, Liu Y, Leoni M; on behalf of the Brimonidine Phase II study group.

University of Louisville, Louisville, KY, USA DermResearch, Inc., Austin, TX, USA Arlington Center for Dermatology, Arlington, TX, USA The Education & Research Foundation, Inc., Lynchburg, VA, USA Philadelphia Institute of Dermatology, Fort Washington, PA, USA University of California at San Francisco, San Francisco, CA, USA Galderma R&D, Princeton, NJ, USA.

Background: Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity.

Brimonidine tartrate (BT) is a highly selective α(2) -adrenergic receptor agonist with vasoconstrictive activity.

Objective: To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety.

Methods: In Study A, 122 subjects were randomized to receive a single application of BT 0.07%, 0.18%, 0.5% and vehicle.

In Study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0.5% once-daily (QD), BT 0.18% QD, vehicle QD, BT 0.18% twice-daily (BID) or vehicle BID. Evaluations included Clinician’s Erythema Assessment (CEA), Patient’s Self Assessment (PSA), chromameter measurements and adverse events.

Results: Study A – A single application of topical BT gel reduced facial erythema in a dose-dependent fashion. Significant difference between BT 0.5% and vehicle in chromameter redness value was observed from 30 minutes to 12 hours after application.

Study B – BT 0.5% QD had a statistically superior success profile (defined as 2-grade improvement on both CEA and PSA over 12 hours) compared to vehicle QD on Days 1, 15 and 29 (all P<.001). No tachyphylaxis, rebound of erythema or aggravation of other disease signs (telangiectasia, inflammatory lesions) was observed. All regimens were safe and well-tolerated with similarly low incidence of adverse events.

Conclusions: Once-daily BT gel 0.5% is well-tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea.

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.

[Update] – Sansrosa has been approved, and is now known as Mirvaso.

Rebound Redness in the Real World

Now that Mirvaso has been released and initial user reviews are surfacing, it appears that rebound redness is indeed an issue for many users of Mirvaso.

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

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2 Reader Comments

  1. William says:

    Great news. I don’t think we’ve ever heard Galderma even address the possibility of rebound, so it’s comforting to see that they’ve discussed it.

    One wonders whether it’s all corporate propaganda, but then again, they’re putting their money where their mouth is by going into Phase 3. There must be at least some faith on their part that Sansrosa will work and will earn them a profit.

    Still, it seems difficult to reconcile the results of the forum members who applied brimonidine to their faces with Galderma’s newest statement. My first thought is that the testers were on a different treatment protocol, but the clinical study information very clearly indicates that they applied the drug every day for 8 weeks. That’s a very significant amount of time to expose testers to a drug that risks producing rebound flushing and tachyphylaxis.

    So maybe there is something different about their formulation. It sounds a little fanciful, but maybe they’ve found a way of compounding the brimonidine in a more benign way. That would be the best outcome for those of us waiting on the drug, of course.

    Either way, I’m very interested in how it will be received when/if it reaches the public. My guess is that it will be approved eventually, barring any devastating Phase 3 results. After all, brimonidine has already been approved by the FDA for glaucoma treatment; this would just be another indication. I think the real question is how effective it will prove as a long-term treatment with a decidedly unbiased public. Here’s to hoping!

  2. David Pascoe says:

    The trial NCT01174030 actually only used the gel for 4 weeks, but as part of an 8 week study that included followup as well. Perhaps some stopped and started during the 8 weeks for them to say that there was no tachyphylaxis.

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