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Lithethefatsi tse ncha bakeng sa lefu la ho tsamaea

2024-05-29

Ka la 15 Motšeanong, Vanda Pharmaceuticals, k'hamphani ea biopharmaceutical ea US, e phatlalalitse hore thuto ea bobeli ea Mokhahlelo oa III oa lithethefatsi tsa eona tse ncha Tradipitant (tradipitant) bakeng sa phekolo ea ho tsamaea (haholo-holo boloetse ba ho tsamaea) e fihletse liphello tse ntle.
Tradipitant ke mohanyetsi oa li-receptor tsa neurokinin-1 (NK1) tse entsoeng ke Eli Lilly. Vanda o fumane litokelo tsa nts'etsopele ea lefats'e tsa Tradipitant ka ho fana ka laesense ka April 2012.
Hajoale, Vanda e thehile Tradipitant bakeng sa matšoao a kang atopic dermatitis pruritus, gastroparesis, ts'oaetso e ncha ea coronavirus, ho kula ho sisinyeha, bokhoba ba tahi, phobia ea sechaba le indigestion.
Thuto ena ea Phase 3 e kenyelelitse bakuli ba 316 ba nang le bothata ba ho tsamaea ba nang le histori ea ho tsamaea, ba ileng ba phekoloa ka 170 mg Tradipitant, 85 mg Tradipitant, kapa placebo nakong ea leeto la sekepe.
Batsayakarolo botlhe ba thutopatlisiso ba ne ba na le ditso tsa malwetse a lewatle. Qetello ea mantlha ea thuto e ne e le phello ea tradipitant (170 mg) ho hlatsa. Lintlha tsa bohlokoa tsa bobeli ke: (1) phello ea tradipitant (85 mg) ho hlatsa; (2) phello ea tradipitant ho thibela ho nyekeloa ke pelo ho matla le ho hlatsa.
Ho tlalehoa hore boloetse ba ho tsamaea e ntse e le tlhoko ea bongaka e sa finyelloang. US Food and Drug Administration (FDA) ha e so ka e amohela sethethefatsi se secha bakeng sa kalafo ea bokuli ba ho sisinyeha ka lilemo tse fetang 40 ho tloha ha e amohela scopolamine (patch ea transdermal e behiloeng ka mor'a tsebe) ka 1979.

Ho ipapisitsoe le lintlha tse tsoang lithutong tse peli tsa Phase III, Vanda e tla kenya kopo ea ho bapatsa bakeng sa tradipitant ho FDA bakeng sa kalafo ea bofokoli ba ho tsamaea kotareng ea bone ea 2024.