Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

Trial Profile

An Open-Label Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 for 40 Weeks in the Treatment of Moderate to Severe Facial Papulopustular Rosacea (Study FX2016-13)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Minocycline (Primary)
  • Indications Rosacea
  • Focus Registrational; Therapeutic Use
  • Sponsors Foamix
  • Most Recent Events

    • 18 Oct 2019 According to a Foamix media release, the U.S. Food and Drug Administration (FDA) has approved its novel AMZEEQTM (minocycline) topical foam, 4%. AMZEEQ, formerly known as FMX101, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.
    • 17 Oct 2019 According to a Foamix media release, the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for FMX103 (minocycline topical foam 1.5%) topical foam, for the treatment of moderate-to-severe papulopustular rosacea in adults. The FDA has set June 2nd, 2020 as the Prescription Drug User Fee Act (PDUFA) action date. The NDA submission is supported by Studies FX2016-11 and FX2016-12 and FX2016-13.
    • 30 Jul 2019 According to an Foamix Pharmaceuticals media, the company has received financing from Perceptive Advisors and OrbiMed which will be used to fund the company's filing of a New Drug Application(NDA) with the FDA for FMX103 for the treatment of papulopustular rosacea. Also the company is in the final stages of preparation for the NDA submission for FMX103.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top