FDA Approves New Antibiotic for Uncomplicated UTIs

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167923</fileName> <TBEID>0C04FE88.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FE88</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240502T145739</QCDate> <firstPublished>20240503T144915</firstPublished> <LastPublished>20240503T144915</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240503T144915</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>J Remaly</byline> <bylineText>JAKE REMALY</bylineText> <bylineFull>JAKE REMALY</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <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 This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.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>The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). The agency on April 24 approved pivmec</metaDescription> <articlePDF/> <teaserImage/> <teaser><span class="Hyperlink">Pivmecillinam</span> is intended to treat UTIs caused by susceptible isolates of <em>Escherichia coli</em>, <em>Proteus mirabilis</em>, and <em>Staphylococcus saprophyticus</em>.</teaser> <title>FDA Approves New Antibiotic for Uncomplicated UTIs</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>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">15</term> <term>21</term> <term>23</term> </publications> <sections> <term canonical="true">37225</term> </sections> <topics> <term canonical="true">234</term> <term>218</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Approves New Antibiotic for Uncomplicated UTIs</title> <deck/> </itemMeta> <itemContent> <p><br/><br/>The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated <span class="Hyperlink"><a href="https://reference.medscape.com/viewarticle/993063">urinary tract infections</a></span> (UTIs). <br/><br/>The agency on April 24 <span class="Hyperlink"><a href="https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections">approved pivmecillinam tablets</a></span> to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.<br/><br/>The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. <br/><br/>The drug is an aminopenicillin that rapidly converts to mecillinam, <span class="Hyperlink"><a href="https://utilitytherapeutics.com/our-focus/">according to the company</a></span>, which is marketing the medication as Pivya. <br/><br/><span class="Hyperlink"><a href="https://reference.medscape.com/drug/pivya-pivmecillinam-100131">Pivmecillinam</a></span> is intended to treat UTIs caused by susceptible isolates of Escherichia coli, <em>Proteus mirabilis</em>, and <em>Staphylococcus saprophyticus</em>. <br/><br/>Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used <span class="Hyperlink"><a href="https://reference.medscape.com/drug/advil-motrin-ibuprofen-343289">ibuprofen</a></span> as the comparator (66% vs 22%). <br/><br/>In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. <br/><br/>The most common side effects of pivmecillinam include nausea and <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/928598-overview">diarrhea</a></span>.<br/><br/>About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted.<span class="end"/> </p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-new-antibiotic-uncomplicated-utis-2024a100087g">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>