{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T19:58:47Z","timestamp":1791921527554,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,11,8]],"date-time":"2021-11-08T00:00:00Z","timestamp":1636329600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of ibrexafungerp versus placebo for acute vulvovaginal candidiasis (VVC) treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Global phase 3, randomised, placebo\u2010controlled superiority study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>\n                      Study sites in the USA (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200919) and Bulgaria (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200918).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Population<\/jats:title>\n                    <jats:p>Female patients aged \u226512\u2009years with acute VVC and a vulvovaginal signs and symptoms (VSS) score \u22654 at baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients were randomly assigned 2:1 to ibrexafungerp (300\u2009mg twice for 1\u2009day) or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The primary endpoint was the percentage of patients with a clinical cure (VSS\u2009=\u20090) at the test\u2010of\u2010cure visit (day 11\u2009\u00b1\u20093). Secondary endpoints included percentages of patients with mycological eradication, clinical cure and mycological eradication (overall success), clinical improvement (VSS\u2009\u22641) at test\u2010of\u2010cure visit, and complete resolution of symptoms at follow\u2010up visit (day 25\u2009\u00b1\u20094).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At the test\u2010of\u2010cure visit, patients receiving ibrexafungerp had significantly higher rates of clinical cure (63.3% [119\/188] versus 44.0% [37\/84];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.007), mycological eradication (58.5% [110\/188] versus 29.8% [25\/84];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001), overall success (46.1% [82\/188] versus 28.4% [23\/84];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.022) and clinical improvement (72.3% [136\/188] versus 54.8% [46\/84];\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.01) versus those receiving placebo. Symptom resolution was sustained and further increased with ibrexafungerp (73.9%) versus placebo (52.4%) at follow\u2010up (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.001). Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mild to moderate in severity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ibrexafungerp demonstrated statistical superiority over placebo for the primary and secondary endpoints. Ibrexafungerp is a promising novel, well\u2010tolerated and effective oral 1\u2010day treatment for acute VVC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Tweetable abstract<\/jats:title>\n                    <jats:p>Ibrexafungerp is statistically superior to placebo for the treatment of vulvovaginal candidiasis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1471-0528.16972","type":"journal-article","created":{"date-parts":[[2021,10,21]],"date-time":"2021-10-21T23:55:12Z","timestamp":1634860512000},"page":"412-420","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["Efficacy and safety of oral ibrexafungerp for the treatment of acute vulvovaginal candidiasis: a\u2009global phase 3, randomised, placebo\u2010controlled superiority study (VANISH 306)"],"prefix":"10.1111","volume":"129","author":[{"given":"R","family":"Sobel","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology Jefferson Vulvovaginal Health Center Sidney Kimmel Medical College Thomas Jefferson University Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Nyirjesy","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Jefferson Vulvovaginal Health Center Sidney Kimmel Medical College Thomas Jefferson University Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MA","family":"Ghannoum","sequence":"additional","affiliation":[{"name":"Department of Dermatology Center for Medical Mycology Case Western Reserve University and University Hospitals Cleveland Medical Center Cleveland OH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"DA","family":"Delchev","sequence":"additional","affiliation":[{"name":"Department of Gynaecology MHAT Dr. Bratan Shukerov AD Smolyan Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"NE","family":"Azie","sequence":"additional","affiliation":[{"name":"Departments of Clinical Development and Medical Affairs SCYNEXIS, Inc. Jersey City NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Angulo","sequence":"additional","affiliation":[{"name":"Department of Clinical Research SCYNEXIS, Inc. Jersey City NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"IA","family":"Harriott","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs SCYNEXIS, Inc. Jersey City NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K","family":"Borroto\u2010Esoda","sequence":"additional","affiliation":[{"name":"KBE Consulting Raleigh NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"JD","family":"Sobel","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department of Internal Medicine Wayne State University Detroit MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,11,8]]},"reference":[{"key":"e_1_2_7_2_1","article-title":"Candidiasis (vulvovaginal)","volume":"16","author":"Martin Lopez JE","year":"2015","journal-title":"BMJ Clin Evid"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/myc.12292"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12905-019-0748-8"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/jof6040267"},{"key":"e_1_2_7_6_1","volume-title":"Vaginal Candidiasis","author":"Jeanmonod R","year":"2021"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003857"},{"key":"e_1_2_7_8_1","first-page":"1","article-title":"Sexually transmitted diseases treatment guidelines, 2015","volume":"64","author":"Workowski KA","year":"2015","journal-title":"MMWR Recomm Rep"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.4155\/fmc-2018-0465"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.3390\/jof6010028"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02611-18"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2020.1791820"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00562-21"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2019.10.088"},{"key":"e_1_2_7_15_1","volume-title":"Vulvovaginal Candidiasis: Developing Drugs for Treatment. 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