Tebchaws Asmeskas pom zoo Trudhesa (dihydroergotamine mesylate) tshuaj tsuag qhov ntswg: 15 feeb ua haujlwm, 2 teev los daws qhov mob!

Impel NeuroPharma tsis ntev los no tshaj tawm tias Asmeskas Cov Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau pom zoo cov tshuaj migraine tshiab Trudhesa (dihydroergotamine mesylate, yav tas los hu ua INP104) tshuaj tsuag qhov ntswg (0.725mg ib tshuaj tsuag): cov tshuaj no yog tshuaj tshiab Dihydroergotamine mesylate (DHE) muab tshuaj rau hauv lub qhov ntswg kab noj sai sai los ntawm lub qhov ntswg kab noj hniav thiab tau siv rau kev kho mob hnyav ntawm cov neeg laus migraine (nrog lossis tsis muaj aura).

Trudhesa siv Impel' s proprietary precision olfactory delivery (POD®) thev naus laus zis, uas tuaj yeem maj mam thauj dihydroergotamine mesylate (DHE) mus rau hauv cov ntshav los ntawm cov ntshav-nplua nuj lub qhov ntswg. Trudhesa hla cov kab mob hauv txoj hnyuv thiab ntau yam cuam tshuam txog kev mob taub hau, xws li xeev siab thiab mob plab, uas tuaj yeem cuam tshuam qhov ua tau zoo ntawm kev kho qhov ncauj. Qhov tseem ceeb, Trudhesa yog cov khoom siv tshuaj ib leeg nkaus xwb uas tuaj yeem siv tau txhua lub sijhawm thaum mob migraine, yog li cov neeg mob tsis tas yuav txhawj xeeb txog qhov tsis muaj sijhawm siv Trudhesa rau qee lub sijhawm. Txawm tias thaum tswj hwm tsis pub dhau ib teev ntawm kev mob taub hau, Trudhesa tuaj yeem muab cov tsos mob sai, txuas ntxiv, thiab zoo ib yam yam tsis tas yuav txhaj tshuaj lossis infusions.

Txawm hais tias ntau txoj kev kho mob tau pom zoo rau kev kho mob hnyav ntawm mob taub hau nyob rau xyoo tas los no, tseem tseem xav tau cov tshuaj kho mob hnyav uas tuaj yeem pab kho thaum ntxov thiab txhawb nqa, yooj yim siv, thiab zam tau zoo. Trudhesa tau cia siab tias yuav mus muag thaum Lub Kaum Hli 2021 thiab yuav muab txoj kev kho mob uas tsis hais qhov ncauj rau cov neeg mob migraine.

Tom qab Trudhesa mus rau tom khw, nws yuav muab txoj kev kho tshiab tseem ceeb rau cov neeg mob migraine. Txoj kev kho ua ke ua haujlwm tau ntev ntawm DHE nrog rau qhov tsis hais lus, tsim kho cov tshuaj tshiab, ua rau cov neeg mob tuaj yeem muaj kev mob taub hau txhua lub sijhawm thiab txhua qhov chaw. Kev tswj tus kheej. Hais txog kev siv tshuaj, qhov pom zoo koob tshuaj Trudhesa yog 1.45mg, uas tau txau los ntawm lub qhov ntswg sab laug thiab sab xis (0.725mg rau ib lub qhov ntswg). Yog tias tsim nyog, koob tshuaj tuaj yeem rov ua dua yam tsawg 1 teev tom qab txhaj thawj zaug. Cov neeg mob yuav tsum tsis txhob siv ntau dua 2 zaug ntawm Trudhesa tsis pub dhau 24 teev thiab tsis pub ntau tshaj 3 zaug hauv 7 hnub.

Dihydroergotamine mesylate (DHE) tau pom zoo rau kev kho mob migraine xyoo 1946 thiab muaj ntau dua 70 xyoo ntawm kev paub kho mob. Kev ua tau zoo ntawm DHE hauv kev kho mob migraine tsis muaj dab tsi ua nrog lub sijhawm pib kho. Tsis zoo li lwm yam kev kho mob migraine, DHE tau paub los khi rau ntau tus neeg txais kev xav raws li qhov pib thiab ntev ntawm kev mob migraine.

Nws tsim nyog hais tias Trudhesa yog thawj zaug thiab tsuas yog cov khoom lag luam uas siv POD thev naus laus zis kom xa DHE mus rau cov hlab ntsha hauv lub qhov ntswg. POD yog ib yam tshiab ntawm kev xa tshuaj tshwj xeeb rau lub qhov ntswg kab noj hniav nplua nuj nyob hauv cov hlab ntshav, uas tuaj yeem muab kev yooj yim thiab cov txiaj ntsig kho mob rau kev kho mob taub hau sai. Cov ntaub ntawv kuaj mob qhia pom tias Trudhesa tau ua zoo. 66% ntawm cov neeg mob tau kho qhov mob hauv 2 teev tom qab kev tswj hwm, thiab qee tus neeg mob tuaj yeem kho qhov mob me me li 15 feeb.

Trudhesa siv Imple's push-type POD thev naus laus zis kom yooj yim thiab xwm yeem xa cov tshuaj pom zoo ntawm DHE mus rau cov hlab ntsha nplua nuj sab saud qhov ntswg. Qhov no yog lub hom phiaj zoo tshaj plaws rau kev tswj hwm zoo, tshwj xeeb tshaj yog rau cov neeg mob migraine feem ntau, uas tshwm sim thaum lub sijhawm tawm tsam. Xeev siab thiab/lossis ntuav, uas txwv kev siv cov tshuaj kho qhov ncauj, suav nrog triptans, calcitonin-ntsig txog peptide (CGRP) inhibitors, ditans, thiab lwm yam tshuaj tshwj xeeb uas tsis muaj mob tshwj xeeb.

Trudhesa cia siab tias yuav dhau los ua qhov tshiab thiab kho tshiab rau kev kho mob hnyav ntawm mob taub hau. Cov khoom lag luam tau tsim los txhawm rau ua kom zoo dua DHE txhawm rau txo kev mob taub hau sai thiab ntev. Nws tuaj yeem muab cov tsos mob sai, txuas ntxiv thiab sib xws tsis hais txog thaum siv cov tshuaj thaum lub sijhawm mob taub hau. Kev pab yam tsis tas yuav txhaj tshuaj lossis infusions. Qhov tseem ceeb, Trudhesa muaj qhov qis dua ntawm DHE tswj los ntawm lub qhov ntswg piv rau FDA pom zoo thiab cov khoom lag luam qis. Qhov no yuav tso cai rau cov neeg mob kom tau txais txiaj ntsig los ntawm kev ua tau zoo ntawm DHE yam tsis muaj kev phom sij ntawm kev tswj hwm qhov ntswg qis.

Adrian Adams, Tus Thawj Coj thiab CEO ntawm Impel NeuroPharma, tau hais tias:" Peb zoo siab nrog kev pom zoo los ntawm Trudhesa los ntawm Asmeskas FDA thiab txaus siab muab qhov kev kho mob tsis hais qhov ncauj rau ntau lab tus neeg mob migraine hauv Tebchaws Meskas. Peb tus tswv POD thev naus laus zis suav nrog Muaj peev xwm qhib lub peev xwm kho tau ntawm txoj kev kho mob yav dhau los uas tsis tau tshawb pom (lub qhov ncauj kab noj hniav sab saud nrog cov hlab ntsha nplua nuj). Kev pom zoo ntawm Trudhesa cim cov txiaj ntsig ntawm kev tsim kho siab tshaj plaws uas tau kawm rau ntau dua kaum xyoo, suav nrog kev ua haujlwm ntawm DHE nrog kev tsim kho tshiab POD thev naus laus zis. Peb Ua tsaug rau txhua tus neeg mob thiab kws tshawb fawb uas koom nrog peb qhov kev sim tshuaj rau coj qhov kev xav tau no mus rau zej zog mob taub hau."