Isicelo Esisha Somuthi Wokwelashwa Okubukhali Kwe-Migraine

I-Axsome Therapeutics, Inc. namuhla imemezele ukuthi Inkampani ithole Incwadi Yempendulo Ephelele (CRL) evela kwa-US Food and Drug Administration (FDA) mayelana ne-New Drug Application (NDA) yayo ye-AXS-07 yokwelashwa okunamandla kwe-migraine. I-CRL ayizange ihlonze noma iveze ukukhathazeka mayelana nokusebenza komtholampilo noma idatha yokuphepha ku-NDA, futhi i-FDA ayizange icele noma yiziphi izivivinyo zomtholampilo ezintsha ukuze isekele ukugunyazwa kwe-AXS-07.

Izizathu eziyinhloko ezinikezwe ku-CRL zihlobene nokucatshangelwa kwamakhemikhali, ukukhiqiza, nokulawula (CMC). I-CRL ihlonze isidingo sedatha eyengeziwe ye-CMC ephathelene nomkhiqizo wezidakamizwa kanye nenqubo yokukhiqiza. U-Axsome ukholelwa ukuthi izinkinga eziphakanyiswe ku-CRL ziyaxazululeka futhi uhlose ukunikeza isikhathi esingase sibe khona sokuthunyelwa kabusha ngemva kokubonisana ne-FDA.

"Kuwumgomo wethu ukusebenzisana ne-FDA ukuze siqonde ngokugcwele futhi sibhekane ngokwanele nokuphawula kwabo, ukuze sikwazi ukwenza lo muthi omusha obalulekile utholakale ezigulini ezine-migraine ngokushesha ngangokunokwenzeka," kusho u-Herriot Tabuteau, MD, i-Chief Executive Officer ye-Axsome. . "Ukugunyazwa kwe-AXS-07 kunganikeza inketho entsha yokwelapha edingeka kakhulu ezigidini zabantu abaphila nalesi simo esintengayo sezinzwa."

I-NDA isekelwa yimiphumela evela ezivivinyweni ezimbili zeSigaba 3 ezingahleliwe, ezingaboni kabili, ezilawulwayo ze-AXS-07 ekwelapheni okunamandla kwe-migraine, ukuhlolwa kwe-MOMENTUM kanye ne-INTERCEPT, okubonise ukuqedwa okuphawulekayo kobuhlungu be-migraine nge-AXS-07 uma kuqhathaniswa ne-placebo. nezilawuli ezisebenzayo.

Abantu baseMelika abangaphezu kwezigidi ezingu-37 bahlushwa i-migraine ngokusho kweCenters for Disease Control, futhi iyimbangela ehamba phambili yokukhubazeka phakathi kokuphazamiseka kwezinzwa e-United States ngokusho kwe-American Migraine Foundation. I-Migraine ibonakala ngokuhlaselwa okuphindaphindiwe kokushaya, ngokuvamile okubuhlungu nokukhubaza ubuhlungu bekhanda obuhambisana nokucanuzela kwenhliziyo, nokuzwela ukukhanya noma umsindo. Kulinganiselwa ukuthi i-migraine ibiza amaRandi ayizigidi eziyizinkulungwane ezingu-78 ngokuqondile (isb ukuvakasha kodokotela, imithi) kanye nokungaqondile (isib. ukuphuthelwa umsebenzi, ukulahlekelwa ukukhiqiza) kubiza unyaka ngamunye e-United States [1]. Ukuhlola okushicilelwe kwabaphethwe yi-migraine kubonisa ukuthi abangaphezu kuka-70% abanelisekile ngokugcwele ngokwelashwa kwabo kwamanje, ukuthi cishe amaphesenti angu-80 azozama ukwelashwa okusha, nokuthi afisa ukwelashwa okusebenza ngokushesha, okungaguquki, futhi kubangele ukuphindaphinda kwezimpawu ezincane.