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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10 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.

    • S.R says:

      Nonsense, Mirvaso is a crap product for many rosacea patients and the negative reviews are everywhere. You sound paranoid for implying that ‘a good proportion’ of the bad press comes from reps. On Rosacea facebook pages I’m on there are dozens of people who wrote about the bad rebound, most traceable as housewives and regular people, no competors reps. If anything, I suspect that a portion of the positive initial glaring reviews came from Galderma reps..

  2. Sa55232 says:

    Hi David,

    Just wanted to ask you if you have heard any new information about this product. I read the article above which says that the phase 3 results were set to end in June. Any updates if you have would be much appreciated.

  3. samoht says:

    what is going on with allergans Oxymetazoline…? does anybody know something?

    • David Pascoe says:

      We do know (May 2016) that oxymetazoline has been submitted for final FDA approval, so that is a good confirmation that it is on the way. I also suspect that it will be called Azultro when launched.

  4. Rob says:

    Ok lets say this ends up working to some extent, I can only imagine what the cost will be. Eye drops cost is what? $10.00 I just don’t see it being affordable and w/o a script. I just bought a couple items from my derm and with insurance and or discount cards I still forked out several hundred dollars and nothing really works that great, my only hope is that I am in the 50% that is lucky enough to have this curse go away on its own after the 9 year sentence I have been given, ( I read it yesterday in one of the dozens of articles I read weekly so that is where I came up with the 9 year figure). My particular problem is my nose keeps breaking out from one side to the other and then to the middle but it never clears up completely and I get red marks that last for weeks and my nose is red all the time. I have been looking to sign up as a guinea pig for new treatments but can never seem to find a study before it starts, do they really do those studies or is it BS like most stuff that is printed, I wonder. I am an optimist for the most part except for this crap. They say there is no cure and no known cause so how can you know where to start treatment if you dont know JACK! Feel a little better now, if I could only sell venting in a bottle.

    • David Pascoe says:

      A constantly healing and re-inflamming nose is what got me started on a quest to beat rosacea – I know that frustration well. All the best in getting the inflammation and any flusing under control that will be key to breaking the cycle.

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