Labaran Waya

Sabon Maganin Maganin Babban Rashin Ciki

Written by edita

AbbVie a yau ta sanar da cewa ta ƙaddamar da ƙarin Sabuwar Aikace-aikacen Magunguna (sNDA) don cariprazine (VRAYLAR®) zuwa Hukumar Abinci da Magunguna ta Amurka (FDA) don haɓakar jiyya na babban rashin ƙarfi (MDD) a cikin marasa lafiya waɗanda ke karɓar ci gaba da maganin antidepressant. . Ana samun goyan bayan ƙaddamar da sakamakon daga gwajin asibiti da aka sanar a baya.

Nazarin 3-3111-301 na Mataki na 001 ya nuna canji na asibiti da ƙididdiga daga tushe zuwa mako shida a cikin Montgomery-Åsberg Depression Rating Scale (MADRS) jimlar ci ga marasa lafiya da aka bi da su tare da cariprazine a 1.5 mg / rana idan aka kwatanta da placebo. Nazarin rajista na biyu na yin rajista, RGH-MD-75, ya nuna canji na asibiti da ƙididdiga daga tushe zuwa mako takwas a cikin jimlar MADRS ga marasa lafiya da aka bi da su tare da cariprazine a 2-4.5 mg / day idan aka kwatanta da placebo. A cikin waɗannan karatun guda biyu, bayanan aminci sun kasance daidai da ƙayyadaddun bayanan tsaro na cariprazine a duk faɗin alamomi, ba tare da sababbin abubuwan da suka faru ba. Hakanan yana goyan bayan ƙaddamarwa shine binciken RGH-MD-76 wanda yayi nazarin aminci na dogon lokaci da haƙuri na cariprazine akan makonni 26.

“Yawancin mutanen da ke fama da babbar matsalar rashin damuwa suna kokawa don neman maganin da zai rage alamun damuwa, tare da ɗaukar shekaru da yawa don samun maganin da ya dace. Cariprazine, lokacin da aka kara da shi zuwa ci gaba da maganin rashin jin daɗi a cikin marasa lafiya tare da babban rashin tausayi, ya nuna cewa zai iya rage alamun rashin tausayi, "in ji Michael Severino, MD, mataimakin shugaban kasa da shugaban kasa, AbbVie. "Muna sa ran yin aiki tare da FDA yayin nazarin ƙaddamarwar mu don kawo wani sabon magani mai mahimmanci ga marasa lafiya da ke fama da rashin tausayi wanda ke shan maganin rigakafi da kuma neman ƙarin taimako. Wannan ƙaddamarwa tana nuna ƙaƙƙarfan ƙudurinmu na magance ƙarin gibi a cikin kula da mutanen da ke fama da cututtukan hauka. "

Ana siyar da Cariprazine azaman VRAYLAR® a cikin Amurka kuma an yarda da FDA don kula da manya masu fama da damuwa, m manic da gauraye abubuwan da ke da alaƙa da cuta ta Bipolar I, da kuma schizophrenia. AbbVie da Gedeon Richter Plc ne ke haɓaka Cariprazine. Fiye da marasa lafiya 8,000 a duk duniya an bi da su tare da cariprazine a cikin fiye da gwaje-gwaje na asibiti na 20 waɗanda ke kimanta inganci da amincin cariprazine don nau'ikan cututtukan hauka.

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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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