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In this phase 3, randomized, double\u2010blind, placebo\u2010controlled, multicenter study, the authors investigated the efficacy and safety of a single patient\u2010initiated dose of amenamevir to treat recurrent herpes labialis. Adult immunocompetent patients with recurrent herpes labialis who had the experience and ability to recognize prodromal symptoms were randomly assigned to administer amenamevir 1200\u2009mg or placebo as a patient\u2010initiated therapy within 6\u00a0hours after onset of prodromal symptoms. The primary efficacy end point was time to healing of all herpes labialis lesions in the modified intention\u2010to\u2010treat population. Secondary efficacy end points were time to crusting of all herpes labialis lesions, time to resolution of pain accompanying herpes labialis, proportion of patients with aborted lesions, and time to resolution of subjective symptoms accompanying herpes labialis. The modified intention\u2010to\u2010treat population, which excluded patients with aborted lesions, comprised 298 patients who self\u2010initiated amenamevir and 307 who took placebo. Amenamevir demonstrated superiority over placebo for the primary end point; the median time to all lesion healing was 5.1\u2009days for amenamevir versus 5.5\u2009days for placebo (hazard ratio, 1.24; 95% confidence interval, 1.06\u20131.46; <jats:italic>p<\/jats:italic>\u00a0=\u20090.0085). Time to crusting of all lesions was significantly shorter with amenamevir versus placebo (<jats:italic>p<\/jats:italic>\u00a0=\u20090.0065); there were no significant between\u2010group differences in other secondary outcomes. Treatment\u2010emergent adverse events in both groups were generally mild in severity; there were two moderate events that were judged unrelated to study treatment, and no severe or serious events. In summary, a single patient\u2010initiated dose of amenamevir 1200\u2009mg taken within 6\u00a0hours of prodromal symptom onset significantly shortened the time to all lesion healing of recurrent herpes labialis compared with placebo, with no clinically important safety concerns.<\/jats:p>","DOI":"10.1111\/1346-8138.16608","type":"journal-article","created":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T07:16:35Z","timestamp":1668064595000},"page":"311-318","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["A phase 3, randomized, double\u2010blind, placebo\u2010controlled study evaluating a single, patient\u2010initiated dose of amenamevir for recurrent herpes labialis"],"prefix":"10.1111","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6877-9979","authenticated-orcid":false,"given":"Makoto","family":"Kawashima","sequence":"first","affiliation":[{"name":"Department of Dermatology Tokyo Women's Medical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Dermatology Aichi Medical University  Aichi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kosuke","family":"Fujio","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Maruho Co., Ltd.  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Komazaki","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Maruho Co., Ltd.  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