I-Fervent Pharmaceuticals imemezele namuhla ukuthi isiqale ucwaningo lwayo lwemitholampilo olungokoqobo ukuze ihlole ukusebenza kahle komkhiqizo wayo wenoveli ekwelapheni izimpawu zokushisa okumaphakathi kuya kokunzima, ukujuluka ebusuku kanye nokuvuka ebusuku ngenxa yokushisa okushisayo. Lo mkhiqizo uhloselwe ukuba utholakale, uma ugunyazwe yi-FDA, ezigulini ngaphandle kwesidingo sencwadi kadokotela. Lolu hlobo locwaningo olukude lungolunye lokuqala lwalo olugunyazwe yi-FDA. Iziguli ocwaningweni zizobamba iqhaza zikude kusukela ekunethezekeni kwamakhaya azo, lapho yonke imikhiqizo yophenyo izolethwa khona, nalapho yonke iqoqo ledatha lizokwenzeka khona.
I-M2S Hot Flash Study iklanyelwe ukubandakanya abesifazane abangasesikhathini sokuya esikhathini kanye nabangemva kokuya esikhathini abaneminyaka engaphezu kuka-45 abahlangabezana okungenani ne-7 kuya ku-8 ukushisa okumaphakathi kuya kokubi kakhulu ngosuku. Abesifazane abahlangabezana nalezi zindlela zokunquma bangafaka isicelo ku-www.m2shotflashstudy.com ukuze bacatshangelwe ukubamba iqhaza kulolu cwaningo lophenyo.
“Ngijabule ngomkhiqizo esiwuphenyayo kanye namathuba ongase ube nawo ekwenzeni ngcono izinga lempilo yalezi ziguli. Ngaphezu kwalokho, ukuba nomklamo wocwaningo oletha kube lula ukubamba iqhaza ngqo ezindlini zeziguli kuvumela iziguli eziningi ukuthi zibambe iqhaza, futhi zenze lokho ngezinhlelo zazo,” kusho uGeorge Royster, uMsunguli/u-CEO we-Fervent Pharmaceuticals. “Sijabule kakhulu ngokwenza lolu cwaningo kanye nokwenza ngcono izimpilo zabesifazane ngokusebenzisa izindlela ezintsha zokwelapha izimpawu zokunqamuka kokuya esikhathini.”
Ukuhlolwa kwamasonto amathathu kwenziwa kutholakale kubahlanganyeli abafanelekayo ezweni lonke. Abahlanganyeli bazocelwa ukuthi balandele izimpawu zabo ze-vasomotor ku-inthanethi ngesikhathi sokuhlolwa futhi baqedele inhlolovo ekupheleni kocwaningo. Imikhiqizo yophenyo ezohlinzekwa ihlanganisa ukwakheka okufakwe ngomlomo, okungewona amahomoni, okungewona amakhambi, okungewona ama-antidepressant enhlanganisela eyaziwa ngezindlela zokwenza izinto, esivele isetshenziswa kabanzi njengenkomba ehlukile, futhi enomlando omude wokusetshenziswa ngokuphepha. . Izinto ezisetshenziswayo zocwaningo zizofaka nezinto zokuqeqesha zokufundisa ababambiqhaza ukuthi bangayisebenzisa kanjani isofthiwe yocwaningo yokubika isiguli.
I-Fervent Pharmaceuticals iyinkampani yokuthuthukisa izidakamizwa yesiteji somtholampilo eyasungulwa eNyakatho ne-Carolina ngo-2011. Igxile ekuthuthukiseni izinga lempilo yabesifazane ngokwakha izindlela zokwelapha eziqondise izidingo ezingahlangatsheziwe empilweni yabesifazane.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The investigational products to be provided include an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, is already widely used for a different indication, and has a long history of safe use.
- The M2S Hot Flash Study is designed to include peri-menopausal and post-menopausal women over the age of 45 who experience at least 7 to 8 moderate to severe hot flashes per day.
- Fervent Pharmaceuticals announced today that it has commenced its virtual clinical study to evaluate the effectiveness of its novel product for the treatment of the symptoms of moderate to severe hot flashes, night sweats and nighttime awakenings due to hot flashes.
