FDA Approves Topical Anticholinergic for Axillary Hyperhidrosis

<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168534</fileName> <TBEID>0C050BBE.SIG</TBEID> <TBUniqueIdentifier>MD_0C050BBE</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240625T100636</QCDate> <firstPublished>20240625T103054</firstPublished> <LastPublished>20240625T103054</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240625T103054</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Doug Brunk</byline> <bylineText>DOUG BRUNK</bylineText> <bylineFull>DOUG BRUNK</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Food and Drug Administration has approved a topical anticholinergic, sofpironium topical gel, 12.45%, for the treatment of primary axillary hyperhidrosis in adu</metaDescription> <articlePDF/> <teaserImage/> <teaser>Approval was based on results from two phase 3 studies that enrolled 710 patients with primary axillary hyperhidrosis.</teaser> <title>FDA Approves Topical Anticholinergic for Axillary Hyperhidrosis</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> <term>25</term> </publications> <sections> <term>37225</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">27442</term> <term>203</term> <term>271</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Approves Topical Anticholinergic for Axillary Hyperhidrosis</title> <deck/> </itemMeta> <itemContent> <p>The <span class="tag metaDescription">Food and Drug Administration has approved a topical anticholinergic, <a href="https://reference.medscape.com/drug/sofdra-sofpironium-topical-4000355">sofpironium topical gel</a>, 12.45%, for the treatment of primary axillary hyperhidrosis in adults and children aged ≥ 9 years</span>.</p> <p>According to <a href="https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299">a press release</a> from Botanix Pharmaceuticals, which developed the product and will market it under the brand name <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf">Sofdra</a>, approval was based on results from two phase 3 studies that enrolled 710 patients with primary axillary hyperhidrosis. In the trials, patients treated with sofpironium topical gel, 12.45%, experienced “clinically and statistically meaningful changes” from baseline in the Gravimetric Sweat Production and the Hyperhidrosis Disease Severity Measure–Axillary seven-item score, according to the company.<br/><br/>Botanix plans to enable qualified patients to gain early access to the product in the third quarter of 2024, with commercial sales expected in the fourth quarter of 2024.<br/><br/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-new-treatment-primary-axillary-hyperhidrosis-2024a1000bs1">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>