Izidakamizwa ezintsha zokugula ukunyakaza

NgoMeyi 15, i-Vanda Pharmaceuticals, inkampani yase-US biopharmaceutical, yamemezela ukuthi ucwaningo lweSigaba III sesibili somuthi wayo omusha i-Tradipitant (tradipitant) yokwelapha ukugula okunyakazayo (ikakhulukazi ukugula okunyakazayo) luzuze imiphumela emihle.
I-Tradipitant iyisamukeli se-neurokinin-1 (NK1) esakhiwe ngu-Eli Lilly. U-Vanda uthole amalungelo okuthuthukisa umhlaba wonke we-Tradipitant ngokunikezwa ilayisense ngo-April 2012.
Njengamanje, i-Vanda ithuthukise i-Tradipitant yezinkomba ezifana ne-atopic dermatitis pruritus, i-gastroparesis, ukutheleleka okusha kwe-coronavirus, ukugula okunyakazayo, umlutha wotshwala, i-phobia social, kanye nokuqunjelwa.
Lolu cwaningo lweSigaba se-3 lwaluhlanganisa iziguli ze-316 ezinyakazayo ezinomlando wokugula okunyakazayo, eziphathwe nge-170 mg Tradipitant, 85 mg Tradipitant, noma i-placebo phakathi nohambo lwesikebhe.
Bonke ababambiqhaza bocwaningo babenomlando wokugula olwandle. Isiphetho esiyinhloko socwaningo kwaba umphumela we-tradipitant (170 mg) ekuhlanzeni. Iziphetho ezibalulekile zesibili yilezi: (1) umphumela we-tradipitant (85 mg) ekuhlanzeni; (2) umphumela we-tradipitant ekuvimbeleni isicanucanu nokuhlanza okukhulu.
Kubikwa ukuthi ukugula okunyakazayo kuseyisidingo sokwelashwa esingahlangatshezwana naye. I-US Food and Drug Administration (FDA) ayizange ivume umuthi omusha wokwelapha isifo sokunyakaza iminyaka engaphezu kwengu-40 kusukela yagunyaza i-scopolamine (i-transdermal patch ebekwe ngemuva kwendlebe) ngo-1979.

Ngokusekelwe kudatha evela ezifundweni ezimbili zeSigaba sesi-III, i-Vanda izothumela isicelo sokumaketha se-tradipitant ku-FDA ukuze zelashwe isifo esinyakazayo ngekota yesine ka-2024.