[{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Bio\u2019s Development Partner, Kaken Pharmaceutical, Submits New Drug Application for Sofpironium Bromide in Japan for Primary Axillary Hyperhidrosis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Bodor Laboratories","sponsor":"Fresh Tracks Therapeutics","pharmaFlowCategory":"D","amount":"$3.5 million","upfrontCash":"$1.0 million","newsHeadline":"Brickell Biotech Announces Settlement of Dispute with Bodor Labs","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Biotech Announces Publication of its U.S. Phase 2b Study Results for Sofpironium Bromide","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Biotech Announces Late-Breaking Oral Presentation at 2020 American Academy of Dermatology Annual Meeting","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Biotech Announces Positive Phase 3 Pivotal Study Results for Sofpironium Bromide in Japan Released by Development Partner","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Kaken Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Biotech Announces Issuance of New Composition of Matter Patent on Sofpironium Bromide by the Japanese Patent Office","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Kaken Pharmaceuticals","sponsor":"Fresh Tracks Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Biotech Announces Approval of Sofpironium Bromide Gel, 5% in Japan for Treatment of Primary Axillary Hyperhidrosis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Fresh Tracks Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brickell Biotech Announces Initiation of U.S. Phase 3 Program Evaluating Sofpironium Bromide Gel","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Brickell Biotech","sponsor":"H.C. 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Find Clinical Drug Pipeline Developments & Deals for Sofpironium Bromide
Sofdra (sofpironium) works by inhibiting M3 muscarinic receptors in eccrine glands. It is approved for the treatment of primary axillary hyperhidrosis in patients ages 9 and older.
Under the agreement, Fresh Tracks provided consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application for BBI-4000 (sofpironium bromide gel).
The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which is expected to submit to the FDA in mid-2022.
Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics.
Brickell Biotech completed patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.
The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis/excessive underarm sweating.
First patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis.
The Cardigan I Study is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%.
Sofpironium bromide gel was deemed to be safe and well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan. Japan is the first country to approve sofpironium bromide with commercial launch expected later this year.
Brickell and Kaken Pharmaceutical were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity.
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