Allergan’s Oxymetazoline Starts Phase 3 Trials for Redness

Allergan have listed their Phase 3 trials details for AGN-199201, their Oxymetazoline based treatment, called AGN-199201, for the persistent red face associated with rosacea.

Phase 3 trials like this one are interested in assessing the safety and efficacy of the active ingredient in a proposed treatment. Efficacy is proved by comparing the active treatment against the treatment’s vehicle carrier. Safety will be assessed by measuring adverse reactions by the investigators and participants.

Possible Competitor to Mirvaso

Allergan are keen to enter the market for treatments for the red face of rosacea, especially now that Mirvaso has been approved. Mirvaso is to date the only prescription product that has been approved by the FDA for a red face.

Allergan are surely watching the generally poor results being reported by users of Mirvaso and hoping for a better product.

What is Oxymetazoline?

Even though this trial doesn’t mention Oxymetazoline we know that that AGN-199201 is the code name for the oxymetazoline based product that Allergan purchased from Vicept Therapeutics.

Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex as well as in eye drops like Visine LR.

A well known side effect of Visine is rebound redness, where continued use leads to the redness that you were originally treating. Extended usage of Afrin can also lead to rebound nasal congestion.

Clinical Trial NCT02131636

Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea

Phase 3

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Experimental: AGN-199201 AGN-199201 applied to the face once daily for 29 days.

Placebo Comparator: Vehicle Vehicle to AGN-199201 applied to the face once daily for 29 days.

Estimated Enrolment: 440

Study Start Date: June 2014

Estimated Study Completion Date: June 2015

Estimated Primary Completion Date: May 2015

 

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About the Author

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

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3 Reader Comments

  1. be serious says:

    No offense, but I would doubt that Allergan is “surely watching” your little website of a few dozen people complaining about side effects that are well recognized and listed on the package insert. BTW, as a former pharmaceutical rep, I can tell you that a good proportion of your “negative reviews” are simply reps from Galderma’s competition writing in to bash the med. It’s pretty standard stuff.

    • alice says:

      People were bashing brimonidine well before Mirvaso came out but Galderma didnt seem to get the memo. Regardless i hope this new drug will work better.

    • David Pascoe says:

      I didn’t mean to imply that that that page was the only place that Allergan might be doing their consumer research. Being an ex rep you would surely know that all owners of large brands do their research to see what is being said about their products. So I don’t doubt that the likes of Allergan and Galderma and Bayer are watching the reception of Mirvaso. Also remember that the AAD has had a recent article also suggesting that dermatologists are seeing higher adverse reactions that the trials suggested. I personally doubt that we will see a press release from Galderma trumpeting the success of Mirvaso any time soon.

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