Labaran Waya

Sabbin Aikace-aikacen Magunguna don Maganin Ciwon Ƙunƙara

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Axsome Therapeutics, Inc. a yau ta sanar da cewa Kamfanin ya karɓi Cikakkiyar Wasiƙar Amsa (CRL) daga Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) game da Sabuwar Drug Application (NDA) don AXS-07 don tsananin maganin ƙaura. CRL ba ta gano ko tada wani damuwa game da ingancin asibiti ko bayanan aminci a cikin NDA ba, kuma FDA ba ta nemi wani sabon gwaji na asibiti don tallafawa amincewar AXS-07 ba.

Babban dalilan da aka bayar a cikin CRL sun shafi la'akarin sunadarai, masana'antu, da sarrafawa (CMC). CRL ta gano buƙatar ƙarin bayanan CMC wanda ya shafi samfurin magani da tsarin masana'antu. Axsome ya yi imanin cewa batutuwan da aka taso a cikin CRL ana iya magance su kuma suna da niyyar samar da yuwuwar lokaci don sake ƙaddamar da shawarwarin da FDA.

Herriot Tabuteau, MD, Babban Jami'in Axsome ya ce: "Manufarmu ne mu yi aiki tare da FDA don fahimtar cikakken fahimta da kuma magance maganganunsu, domin mu iya samar da wannan muhimmin sabon magani ga marasa lafiya da migraine da sauri," in ji Herriot Tabuteau, MD, Babban Jami'in Axsome. . "Yin amincewa da AXS-07 zai ba da sabon zaɓin magani na injiniyoyi da yawa da ake buƙata don miliyoyin mutanen da ke rayuwa tare da wannan yanayin rashin lafiya."

NDA yana goyan bayan sakamako daga 3 Phase guda biyu bazuwar, makafi biyu, gwajin gwaji na AXS-07 a cikin matsanancin jiyya na migraine, gwajin MOMENTUM da INTERCEPT, wanda ya nuna mahimmancin kawar da ciwon migraine tare da AXS-07 idan aka kwatanta da placebo. da sarrafawa masu aiki.

Fiye da Amurkawa miliyan 37 suna fama da ƙaura a cewar Cibiyar Kula da Cututtuka, kuma shine babban dalilin nakasa a tsakanin cututtukan ƙwayoyin cuta a cikin Amurka bisa ga Gidauniyar Migraine ta Amurka. Migraine yana da yawan hare-hare na bugun jini, sau da yawa mai tsanani da nakasa ciwon kai da ke hade da tashin zuciya, da kuma sanin haske da sauti. An kiyasta cewa migraines yana da dala biliyan 78 kai tsaye (misali ziyarar likita, magunguna) da kuma kai tsaye (misali aikin da aka rasa, asarar yawan aiki) farashin kowace shekara a Amurka [1]. Binciken da aka buga na masu fama da ciwon ƙaura ya nuna cewa fiye da kashi 70 cikin 80 ba su cika gamsuwa da jiyyarsu na yanzu ba, cewa kusan kashi XNUMX cikin ɗari za su gwada sabon magani, kuma suna sha'awar jiyya da ke aiki da sauri, da tsayin daka, kuma suna haifar da ƙarancin sake dawowa.

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edita

Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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