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Ann: Botanix Presents at Fall Clinical Dermatology Conference, page-145

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  1. 3,544 Posts.
    lightbulb Created with Sketch. 318
    i tried tagging this above my a 3minute time limit got me.


    cut and paste

    back to my earlier note - this released this morning.


    Foamix Pharmaceuticals’ topical antibiotic for rosacea met its coprimary endpoints in two phase 3 trials. The drug achieved “treatment success” in about half of the 1,522 patients enrolled in the trials and decreased the number of inflammatory lesions from baseline.

    The company, which has offices in Rehovot, Israel, and Bridgewater, New Jersey, expects to report further data, including from a long-term safety extension study, into the first half of next year.


    “Assuming all goes well, we anticipate we will be in a position to file an NDA toward the end of next year,” said Foamix CEO David Domzalski.

    !

    The drug, FMX103, is a foam formulation of 1.5% minocycline, an oral antibiotic used to treat a variety of bacterial infections, such as urinary tract infections and respiratory infections, as well as skin infections. It can be used to treat moderate to severe rosacea, but like other oral antibiotics, it can lead to nasty side effects, including dizziness, nausea, severe stomach pain and skin rash or skin lesions.


    mino bloody cycline folks is as old as I am. normally orally. again a regifted drug. no innovation.


    “The phase 3 results signal efficacy and an excellent safety profile,” Domzalski said. “Specifically, we’re not seeing the systemic side effects you see with systemic therapies. There are very low dermal side effects.”

    The trials, FX2016-11 and FX2016-12, were identical, double-blind, randomized, vehicle-controlled studies that enrolled 751 and 771 patients, respectively. The patients, all adults, had moderate to severe papulopustular rosacea. Over 12 weeks, two-thirds of the patients received a daily dose of FMX103 and one-third received vehicle foam.


    any chance for our cbd for rosacea ?


    the mind boggles




 
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