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An interesting development in rosacea clinical trials is the emergence of a new company called Actavis.
Actavis have listed a large trial where they plan to test their Brimonidine Gel against Galderma’s recently FDA approved Brimonidine-based Mirvaso Gel.
The large Phase 3 trial will compare the response after 7 days.
Up to 462 patients in 16 locations across the US will be examined.
The study was due to start in July and complete this month.
This trial announcement does not address how Actavis, a maker of generic prescriptions, will be able to market a treatment that is covered by patents owned by Galderma.
Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
Sponsor: Actavis Inc.
Collaborator: Watson Laboratories, Inc.Full Title: A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso (Brimonidine) Topical Gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients With Moderate to Severe Facial Erythema Associated With Rosacea
Primary Outcome Meansure: Proportion of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1).
Not directly connected but this is interesting “Actavis to buy Allergan”
see http://www.bbc.co.uk/news/business-30084329
Yes Actavis suddenly became a lot more interesting to rosacea sufferers.
This can only be good news,as treatment for rosacea runs over months any treatment that can under cut that time can only be great news for all people who suffer ROSACEA….
All of this kind of news is encouraging but disheartening at the same time, for example there was an article about 1% ivermectin cream with great potential that was written early this year stating patent approval later this year, well it’s pretty much already later this year and no word whatsoever and that seems to be the norm. A word to big drug representatives.., If you are going to get us all excited about promising new product then periodic updates would be greatly appreciated otherwise please don’t say anything.
So is this a clinical trial of a generic version of Mirvaso?
any news about this ? what is going to happen with actavis ? are they having a product which will come to the market soon ?
This item was written just 1 month ago and is about a trial that may complete shortly. It can be years from the completion of a trial until a product becomes available.
had a bad reaction to mirvaso — how long before the redness from the reaction goes away