Finacea Foam approval expected in August

Written by on April 1, 2015 in Finacea (Azelaic Acid 15%), research with 0 Comments

A session at the recent 2015 AAD meeting in San Francisco offered the following summary of the status of the development of the Finacea Foam product.

Probably the most interesting new bit of information is that Finacea Foam is expected to approved in August this year.

What’s New in Rosacea Therapy?

Zoe Diana Draelos, MD

Azelaic Acid Foam Phase 3

  • 2 parallel Phase 3 studies in subjects with moderate to severe papulopustular rosacea
  • 48 study centers, 18+ years, twice daily, received either active (n=484) or vehicle (n=477) for 12 weeks
  • Subjects evaluated at 4, 8, 12 weeks of treatment, subjects followed up 4 weeks post treatment
  • 5 g foam of foam contained 75 mg AzA, total daily dose of 150 mg AzA applied to an estimated 750 to 1000 cm2 of skin

New AzA Foam Formulation

  • Phase III parallel studies submitted to the FDA for approval
  • Approval anticipated in August 2015
  • Excellent safety profile
  • Offers foam rosacea treatment not currently in marketplace

Update

Finacea Foam (azelaic acid 15%) approved by the FDA

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About the Author

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

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