From the International Hyperhydrosis web page. Read it to rrassure yourselves, this trial was supported by the organisation....DYOR
https://www.sweathelp.org/hyperhidrosis-treatments/treatments-in-development.htmlBotanix’s Sofpironium Bromide Topical Gel May Be Approved Soon
Anew topicalfromBotanixmay be approved by the U.S. FDA in late 2023 or early 2024 for primary axillary hyperhidrosis (underarm excessive sweating).
The product (sofpironium bromide 15%gel) is an anticholinergic/antimuscarinic drug that blocks sweating at the gland level by binding to a receptor and interrupting the sweat signal. Users apply the gel to the underarms with an applicator that helps prevent the medication from getting on hands by mistake.
Botanix says it has submitted a New Drug Application (NDA) to the FDA for US regulatory approval and has received confirmation that it is suitable for substantive review and that no issues have been identified. A similar product (Ecclock® sofpironium bromide 5%) was approved in Japan and launched by Botanix’s partner Kaken Pharmaceutical Co., Ltd. (See info on that below)
Sofpironium bromide 15% went through two Phase 3 trials in the USA and IHhS is proud to have helped recruit participants for these trials. The two trials (called “Cardigan I” and “Cardigan II”) lasted eight weeks (per participant) and included about 350 hyperhidrosis sufferers each. Study volunteers were aged nine years and older and all were diagnosed with primary axillary hyperhidrosis. As you may know, Phase 3 trials are conducted to confirm and expand knowledge of safety and effectiveness results from Phase 1 and 2 trials and to compare the new product to other standard therapies. Phase 3 trials also look at the overall risks and benefits of a new treatment.
Results showed that more than 60% of study participants had a 50% or greater reduction in sweat production and that 85% of patients using the sofpironium bromide gel experienced a clinically meaningful improvement in their condition. The most common side effects reported were dry mouth and blurred vision. These were usually mild or moderate and temporary. There were no treatment related serious adverse events in any of the studies.
Studiesalso looked at the use of sofpironium bromide 15% for children aged 9 to 16 suffering from primary axillary hyperhidrosis (underarm excessive sweating). The young people with Hh in this study used sofpironium bromide for more than 5 months with no severe or serious side effects and reported meaningful improvement in their underarm sweating symptoms (an approximately 65% improvement in how they described their sweating severity). Two participants did, however, stop using the skin treatment due to dry eyes, dry mouth, itching, and rash.
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