https://www.auvelityhcp.com/f9f403e97aef12798492542f01bb622049406886-e8281cef46bd02d706c9.js

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Patients received Auvelity once daily for the first 3 days and twice daily thereafter."};return(0,l.Y)(a.Fragment,null,(0,l.Y)(n.Sz,{css:d},"COMET Phase 3 Study"),(0,l.Y)(n.QR,{css:m},"COMET was a Phase 3, multicenter, open-label US study. Patients with MDD were treated with AUVELITY twice daily in a 12-month study. The study enrolled both patients completing a prior AUVELITY study and newly enrolled patients. The trial was concluded once at least 300 patients had been treated for 6 months and at least 100 patients had been treated for 12 months, as prespecified. At the time of study conclusion, 597 patients had reached at least 6 months, and 110 patients had reached at least 12 months of treatment.",(0,l.Y)("sup",null,"1,2")),(0,l.Y)(s.A,{images:[e],fullWidthChart:!0,noMargin:!0,mobileExtraExtraLargeSpace:!0,objectFit:"fill",mobilePointer:"top"}),(0,l.Y)(n.QR,{css:p},"Efficacy endpoint results were based on the newly enrolled patients (n=609) and the safety results from the full population (n=876).",(0,l.Y)("sup",null,"3,5")),(0,l.Y)(n.QR,{css:c},"All newly enrolled patients were assessed for efficacy through Week 6. Only patients whose MADRS scores improved by ≥25% were eligible to continue in the study. 6% of subjects met discontinuation criteria at Week 6.",(0,l.Y)("sup",null,"1,6")),(0,l.Y)(n.QR,{css:g},"Select secondary endpoints include: clinical remission (MADRS total score ≤10), clinical response (≥50% improvement in MADRS total score from baseline), CGI-I, and SDS.",(0,l.Y)("sup",null,"1")),(0,l.Y)(n.QR,null,"Clinical response and clinical remission were assessed on the MADRS scale. The MADRS is a clinician-rated scale used to assess depressive symptom severity. Patients are rated on 10 items to assess feelings of sadness, inner tension, reduced sleep or appetite, difficulty concentrating, lassitude, lack of interest, pessimism, and suicidality. Scores range from 0 to 60, with higher scores indicating more severe depression.",(0,l.Y)("sup",null,"1,4")),(0,l.Y)(n.wc,{nopadding:!0,marginTop:!0,content:""},"BID=twice a day; CGI-I=Clinical Global Impression-Improvement; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; SDS=Sheehan Disability Scale."))}},7782:function(e,t){t.A="data:image/svg+xml;base64,PHN2ZyB3aWR0aD0iNDQiIGhlaWdodD0iNDQiIHZpZXdCb3g9IjAgMCA0NCA0NCIgZmlsbD0ibm9uZSIgeG1sbnM9Imh0dHA6Ly93d3cudzMub3JnLzIwMDAvc3ZnIj4KPHBhdGggZD0iTTQzIDQzTDQzIDNMMyA0M0w0MyA0M1oiIGZpbGw9IiNGRkMwMDAiIHN0cm9rZT0iI0ZGQzAwMCIgc3Ryb2tlLXdpZHRoPSIyIiBzdHJva2UtbWl0ZXJsaW1pdD0iMTAiLz4KPC9zdmc+Cg=="},8157:function(e,t,i){var a=i(6540),n=i(7373),s=i(5409),o=i(3645),r=i(7437);var l={name:"1bmnxg7",styles:"white-space:nowrap"},d={name:"akdqam",styles:"margin-top:1rem"},m={name:"16ceglb",styles:"font-weight:600"},p={name:"1d3w5wq",styles:"width:100%"},c={name:"1loen0n",styles:"text-align:center;padding:0px;margin-top:1.5rem"},g={name:"1y6hgtu",styles:"font-weight:400;margin-left:0.25rem;margin-right:0.25rem"},u={name:"p86vup",styles:"text-align:center;border-bottom-width:2px;--tw-border-opacity:1;border-color:rgba(255, 255, 255, var(--tw-border-opacity))"},h={name:"5jeq4h",styles:"padding:0.75rem;text-align:left;color:rgba(2, 0, 0, 0.8);@media (min-width: 1024px){width:40%;}"},y={name:"1ltkldv",styles:"padding:0.75rem;--tw-bg-opacity:1;background-color:rgba(255, 192, 0, var(--tw-bg-opacity));--tw-text-opacity:1;color:rgba(33, 23, 75, var(--tw-text-opacity));border-top-left-radius:2rem"},b={name:"1azakc",styles:"text-align:center"}

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1,"No reported cases of tardive dyskinesia in the COMET trial",(0,r.Y)("sup",null,"6"))),(0,r.Y)("div",{css:S},(0,r.Y)(n.$n,{addedStyles:{padding:"30px 15px 30px 25px",lineHeight:"1.25"},play2:!0,onClick:e=>{(0,o.k7)(e,"/mdd/video-library/#1081585396")}},"Watch Dr Stephen M Stahl and Dr Lara Shirikjian discuss the COMET trial")),(0,r.Y)(s.A,{css:z},(0,r.Y)(n.Sz,{css:T},"Clinical study overview"),(0,r.Y)(n.QR,null,(0,r.Y)("span",{css:E},"COMET")," was a 12-month, Phase 3, multicenter, long-term, open-label safety study assessing AUVELITY (twice daily) in 876 patients (rollover from prior AUVELITY studies and newly enrolled) with MDD. Efficacy measures were secondary endpoints based on newly enrolled patients (n=609).",(0,r.Y)("sup",null,"1,2,7,8")," ",(0,r.Y)(n.uf,{href:"/mdd/long-term-data/comet-study-design",css:N},"See full study design"),".")))}},8639:function(e,t,i){i.d(t,{A:function(){return I}});var a=i(6540),n=(i(9254),i(7373)),s=i(6506),o=i.p+"static/remission-59df643daeaf324c9bcae00ae2fcc400.svg",r=i.p+"static/remission-mobile-8ee0a5314fffd0c3a768d937f6b72aa5.svg",l=i.p+"static/response-99a9f381991e701f9485a51fdc08e942.svg",d=i.p+"static/response-mobile-82e673585e3c5d642caeadc92b5994c2.svg",m=i(7437);var p={name:"1h026t7",styles:"margin-bottom:1.5rem"},c={name:"1hahsgh",styles:"display:none;@media (min-width: 1024px){display:inline;}"},g={name:"1y34fmm",styles:"margin-top:30px;margin-bottom:2.5rem;@media (min-width: 1024px){margin-bottom:0px;}"},u={name:"1fy4fvl",styles:"font-size:22px !important;font-weight:400;--tw-text-opacity:1;color:rgba(33, 23, 75, var(--tw-text-opacity));text-align:center;justify-content:center"},h={name:"hhm3k5",styles:"--tw-text-opacity:1;color:rgba(33, 23, 75, var(--tw-text-opacity));text-align:center;font-size:20px !important;leading=:28px !important;margin-bottom:2rem;margin-top:0px;@media (min-width: 1024px){margin-bottom:0px;padding-bottom:1.25rem;height:60px;}@media (min-width: 1280px){white-space:nowrap;}"},y={name:"1fy4fvl",styles:"font-size:22px !important;font-weight:400;--tw-text-opacity:1;color:rgba(33, 23, 75, var(--tw-text-opacity));text-align:center;justify-content:center"},b={name:"hhm3k5",styles:"--tw-text-opacity:1;color:rgba(33, 23, 75, var(--tw-text-opacity));text-align:center;font-size:20px !important;leading=:28px !important;margin-bottom:2rem;margin-top:0px;@media (min-width: 1024px){margin-bottom:0px;padding-bottom:1.25rem;height:60px;}@media (min-width: 1280px){white-space:nowrap;}"},w={name:"1soiukc",styles:"@media (min-width: 1024px){margin-top:30px;}@media (min-width: 1280px){margin-top:35px;}"},f={name:"deyndc",styles:"font-size:18px !important;line-height:21px !important;font-weight:700"},x={name:"1l55ehc",styles:"font-size:18px !important;line-height:21px !important;margin-top:10px"},Y={name:"jsc5h4",styles:"font-size:18px !important;line-height:21px !important;margin-bottom:10px;margin-top:10px"};var I=()=>(0,m.Y)(a.Fragment,null,(0,m.Y)(n.Sz,{css:p},"Long-term safety and effectiveness were measured for"," ",(0,m.Y)("br",{css:c}),"AUVELITY in an open-label study",(0,m.Y)("sup",null,"1")),(0,m.Y)(n.QR,null,(0,m.Y)("strong",null,"AUVELITY had a demonstrated safety profile in a study lasting up to 12 months.")," ","The most common adverse events experienced in ≥5% of AUVELITY-treated patients were dizziness (12.7%), nausea (11.9%), headache (8.8%), dry mouth (7.1%), and decreased appetite (6.1%). Long-term safety data up to 12 months were consistent with the controlled clinical studies.",(0,m.Y)("sup",null,"2-4")),(0,m.Y)("div",{className:"sidebyside setsize margin-top-mobile",css:g},(0,m.Y)(n.Sz,{css:u},"Protocol-defined ",(0,m.Y)("strong",null,"remission"),(0,m.Y)("sup",null,"5,6"),"*",(0,m.Y)("sup",null,"†")),(0,m.Y)(n.QR,{css:h},"MADRS total score ≤10 (estimated PHQ-9 of 8)"),(0,m.Y)(s.A,{images:[{src:o,mobileSrc:r,hideSwipe:!0,alt:"Bar graph showing percentage of patients achieving remission in the long-term COMET study"}],noMarginTop:!0})),(0,m.Y)("div",{className:"sidebyside setsize"},(0,m.Y)(n.Sz,{css:y},"Protocol-defined ",(0,m.Y)("strong",null,"response"),(0,m.Y)("sup",null,"5,6"),"*",(0,m.Y)("sup",null,"†")),(0,m.Y)(n.QR,{css:b},"≥50% improvement in MADRS",(0,m.Y)("br",null),"total score from baseline"),(0,m.Y)("div",{css:w},(0,m.Y)(s.A,{images:[{src:l,mobileSrc:d,hideSwipe:!0,alt:"Bar graph showing percentage of patients achieving response in the long-term COMET study"}],noMarginTop:!0}))),(0,m.Y)(n.QR,{css:f},"Data from open-label studies have limitations. As the study was not blinded or placebo-controlled, results should be interpreted with these factors in mind. Endpoints were analyzed descriptively, and statistical significance cannot be attributed."),(0,m.Y)(n.QR,{css:x},"All newly enrolled patients were assessed for efficacy through Week 6. Only patients whose MADRS scores improved by ≥25% were eligible to continue in the study. 6% of subjects met discontinuation criteria at Week 6.",(0,m.Y)("sup",null,"1,7")),(0,m.Y)(n.QR,{css:Y},"The decrease in patient number over time is primarily due to staggered entry into the study and the closing of the study once enrollment goals were met.",(0,m.Y)("sup",null,"1")),(0,m.Y)(n.wc,null,"AUVELITY-naïve ITT population.",(0,m.Y)("sup",null,"5")),(0,m.Y)(n.wc,{content:(0,m.Y)("sup",null,"†"),icon:!0},"Missing data were not imputed. Efficacy data from early termination visits were included in the summary of the next scheduled efficacy assessment visit.",(0,m.Y)("sup",null,"1")),(0,m.Y)(n.wc,{content:"",marginTop:!0},"BID=twice a day; ITT=intention-to-treat; MADRS=Montgomery-Åsberg Depression Rating Scale."))},9183:function(e,t){t.A="data:image/svg+xml;base64,PHN2ZyB3aWR0aD0iNDIiIGhlaWdodD0iNDIiIHZpZXdCb3g9IjAgMCA0MiA0MiIgZmlsbD0ibm9uZSIgeG1sbnM9Imh0dHA6Ly93d3cudzMub3JnLzIwMDAvc3ZnIj4KPHBhdGggZD0iTTQxIDFIMVY0MUg0MVYxWiIgZmlsbD0iI0QwRDFEQiIgc3Ryb2tlPSIjRDBEMURCIiBzdHJva2Utd2lkdGg9IjIiIHN0cm9rZS1taXRlcmxpbWl0PSIxMCIvPgo8L3N2Zz4K"}}]);
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