FDA approves Astepro, new formulation of Astelin

The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray.

The active substance in these products is azelastine - the leading nasal antihistamine in the treatment of rhinitis in the U.S.

Astepro is now approved for treatment of seasonal allergic rhinitis. Fewer reports of bitter taste and nasal discomfort were recorded by Astepro users and it was in general better tolerated than Astelin. Symptom relief, as recorded by patients, was also better. In total, about 1,400 patients were involved in Meda's phase III studies.

"Our development team has done an excellent work answering the questions from FDA and reaching approval in such a short time. This is an important milestone for Meda", said Anders Lönner, CEO Meda.

Full launch of Astepro in the U.S. will take place well before the next allergic rhinitis season.

Comments

  1. Shari Firestone Shari Firestone United States says:

    Unfortunately, I was told that I could no longer use the only medicine that works for me, Astelin.  So, I tried Astepro and was more stuffed up than when I started.  And, my nose started to run.  And, the taste is even worse for me.  I thought that I was going to throw up when it hit the back of my throat after going up my nose.  I guess that I'm just one of those people where Astelin worked better.  This Astepro made me gag quite a bit.

    I'm hoping that this was just a bad first experience because Iam stuck with this formula.

  2. Telenor Tolsive Telenor Tolsive United States says:

    Does Astepro reduce sex drive. For several months now, I have been taking two doses at bedtime.

  3. Jim McCarthy Jim McCarthy United States says:

    I switched to Astepro some months ago after having problems with Astelin. Astepro worked better, faster, and with less after taste. And I'm breathing better, longer. Local MD's told me there's no difference. I told them "Buffalo Chips", and I'm walking, talking, better breathing proof. Try Astepro, it works for me...a lifelong broadcaster for whom nothing else worked.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
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