Kaomi ma aneʻi e hōʻike i kāu mau hae ma kēia ʻaoʻao a uku wale no ka holomua

Nuhou Uea

Laau Laau Laau Hou no ka Lapaau Ake o Migraine

i kakauia ma hoʻoponopono

Ua hoʻolaha aku ʻo Axsome Therapeutics, Inc. i kēia lā ua loaʻa i ka Hui kahi leka pane piha (CRL) mai ka US Food and Drug Administration (FDA) e pili ana i kāna New Drug Application (NDA) no AXS-07 no ka mālama ʻana i ka migraine. ʻAʻole i ʻike a hāpai ʻia ka CRL i kekahi hopohopo e pili ana i ka pono lapaʻau a i ʻole ka ʻikepili palekana i ka NDA, a ʻaʻole i noi ka FDA i nā hoʻokolohua lapaʻau hou e kākoʻo i ka ʻae ʻana o AXS-07.

ʻO nā kumu nui i hāʻawi ʻia ma ka CRL e pili ana i ka noʻonoʻo ʻana i ka kemika, ka hana ʻana, a me nā mana (CMC). Ua ʻike ka CRL i ka pono o ka ʻikepili CMC hou e pili ana i ka huahana lāʻau a me ke kaʻina hana. Manaʻo ʻo Axsome he hiki ke hoʻoponopono ʻia nā pilikia i hāpai ʻia ma ka CRL a manaʻo e hāʻawi i ka manawa kūpono no ka hoʻouna hou ʻana ma hope o ke kūkākūkā ʻana me ka FDA.

"ʻO kā mākou pahuhopu e hana pū me ka FDA e hoʻomaopopo pono a hoʻoponopono pono i kā lākou mau ʻōlelo, i hiki iā mākou ke hoʻolako i kēia lāʻau lapaʻau koʻikoʻi i nā poʻe maʻi me ka migraine i ka wikiwiki," wahi a Herriot Tabuteau, MD, Luna Nui o Axsome . "ʻO ka ʻae ʻana o AXS-07 e hāʻawi i kahi koho lapaʻau multi-mechanistic hou i makemake nui ʻia no nā miliona o ka poʻe e noho nei me kēia maʻi neurological hoʻonāwaliwali."

Kākoʻo ʻia ka NDA e nā hopena mai ʻelua Phase 3 randomized, double-blind, controlled trials o AXS-07 i ka mālama ʻana i ka migraine, ka MOMENTUM a me INTERCEPT hoʻāʻo, ka mea i hōʻike i ka hoʻopau ʻana i ka ʻeha migraine me AXS-07 i hoʻohālikelike ʻia me kahi placebo. a me nā mana ikaika.

Ma luna o 37 miliona ʻAmelika e loaʻa i ka migraine e like me ka Centers for Disease Control, a ʻo ia ke kumu nui o ke kīnā ma waena o nā maʻi neurological ma United States e like me ka American Migraine Foundation. Hōʻike ʻia ka Migraine e ka hoʻouka pinepine ʻana o ka puʻupuʻu, pinepine a me ka ʻeha o ke poʻo e pili ana i ka nausea, a me ka naʻau i ka mālamalama a i ʻole ke kani. Ua manaʻo ʻia he $78 biliona ka nui o ka migraine ma ke ʻano pololei (e laʻa me ke kipa kauka, nā lāʻau lapaʻau) a me nā kumu kūʻai ʻole (e laʻa me ka hana ʻole, nalowale ka huahana) i kēlā me kēia makahiki ma United States [1]. ʻO nā noiʻi i hoʻopuka ʻia no ka poʻe maʻi migraine e hōʻike ana ʻoi aku ka nui o ka 70% ʻaʻole i ʻoluʻolu piha i kā lākou mālama ʻana i kēia manawa, kokoke 80% e hoʻāʻo i kahi lāʻau lapaʻau hou, a makemake lākou i nā lapaʻau e ʻoi aku ka wikiwiki, ʻoi aku ka paʻa, a me ka emi ʻana o ka hōʻailona.

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ʻO Linda Hohnholz ka Lunahooponopono no eTurboNew. Aia ʻo ia ma ka eTN HQ ma Honolulu, Hawaii.

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