Hōʻike (hoʻohana ʻia): I ka makahiki 2019, ua ʻae ka FDA no ka mālama ʻana i ka maʻi i loaʻa, generalized hypoactive sexual desire disorder (HSDD) i nā wahine premenopausal i ka wā e hōʻeha ai ke kūlana a ʻaʻole ma muli o nā kūlana olakino/psychiatric a i ʻole nā hopena ʻaoʻao lāʻau.
Mechanism of Action
ʻO ka PT-141 he agonist melanocortin receptor agonist (ma mua o ka MC4 receptor) e hoʻololi i ka makemake i ka wahine ma o nā ala o ke kikowaena pūnaewele.
ʻAʻole like me ka PDE5 inhibitors (eg, sildenafil), ka mea nui e hoʻopili i nā kīʻaha koko, hana ʻo PT-141 i ke kikowaena e hoʻopilikia i ka hoʻoikaika a me ka hoʻoulu.
Pharmacology & Dosing
Hoʻoponopono: ʻO ka hoʻokele subcutaneous, e like me ka mea e pono ai (ma ke koi).
ʻApono ʻia: 1.75 mg sc
Pharmacokinetics:
Tmax ≈ ~60 minuke
t½ ≈ 2–3 hola
Hiki i nā hopena ke lōʻihi i kekahi mau hola, i kekahi mau hōʻike a hiki i ~16 hola.
ʻO ka maikaʻi o ka maʻi maʻi (Phase III Ho'āʻo - RECONNECT, 24 wiki, RCTs)
Nā helu hope mua:
Ka Papa kuhikuhi Hana Hana Wahine–Ka puni makemake (FSFI-D)
Kauna o ka pilikia o ka wahine (FSDS-DAO)
Nā hualoaʻa koʻikoʻi (nā haʻawina hui 301 + 302):
Hoʻomaikaʻi FSFI-D: +0.35 vs placebo (P<0.001)
Hoʻemi ka helu FSDS-DAO: −0.33 vs placebo (P<0.001)
ʻO nā hopena ʻē aʻe: ʻO nā hopena kākoʻo (nā helu hana wahine, hōʻike ʻia i ka mea maʻi) i kūpono i ka maikaʻi, akā ʻaʻole i hōʻike mau nā hanana moe kolohe (SSEs) i nā ʻokoʻa koʻikoʻi.
Nā hanana pōʻino (hōʻike pinepine ʻia i nā hoʻokolohua)
Maʻamau (≥10%):
Nausea (~ 30–40%; a hiki i ~40% i hōʻike ʻia ma nā hoʻāʻo)
ʻO ka holoi ʻana (≥10%)
ʻEha poʻo (≥10%)
Nā hopena maʻi cardiovascular:
Ua ʻike ʻia ka piʻi ʻana o ke koko a me nā loli o ka puʻuwai puʻuwai, maʻamau e hoʻoholo i loko o kekahi mau hola.
Contraindicated a hoʻohana ʻia me ka akahele i nā poʻe maʻi me ka maʻi hypertension ʻole a i ʻole ka maʻi cardiovascular.
Ake: nā hōʻike kakaʻikahi o ka piʻi ʻana o ka enzyme ate; Hōʻike nā hōʻike hihia kakaʻikahi hiki ke hōʻeha i ka ate, akā ʻaʻole maʻamau.
Palekana no ka wā lōʻihi (Hoʻonui Haʻawina)
Ua loaʻa i kahi haʻawina hoʻonui ʻia he 52 pule i ka hoʻomaikaʻi ʻana i ka makemake me ka ʻole o nā hōʻailona palekana hou.
ʻO ka moʻolelo palekana no ka wā lōʻihi i manaʻo ʻia he ʻae maikaʻi ʻia, me nā pilikia koʻikoʻi no ka hoʻomanawanui ʻana he mau hopena pōʻino no ka wā pōkole e like me ka nausea.
Nā memo hoʻohana nui
Ua kaupalena ʻia ka heluna kanaka i ʻāpono ʻia: No nā wahine premenopausal wale nō me ka HSDD i loaʻa.
ʻAʻole i ʻae ʻia no nā kāne (ED a i ʻole makemake haʻahaʻa i nā kāne ke hoʻomau nei ka hoʻokolokolo).
He mea koʻikoʻi ka nānā ʻana i ka palekana: ʻO ke kiʻekiʻe, ka maʻi cardiovascular, a me ka mōʻaukala ate pono e loiloi ʻia ma mua o ke kau ʻana.
Hōʻuluʻulu ʻikepili wikiwiki
ʻAe ʻia ka FDA: 2019 (Vyleesi).
ʻAi: 1.75 mg subcutaneous injection, ma ke koi.
PK: Tmax ~60 min; t½ 2–3 hola; nā hopena a hiki i ~16 h.
Pono (Phase III, hui pū ʻia):
FSFI-D: +0.35 (P<.001)
FSDS-DAO: −0.33 (P<.001)
Nā hanana pōʻino:
Nausea: a hiki i ~40%
ʻO ka holoi ʻana: ≥10%
ʻEha poʻo: ≥10%
Hoʻonui ʻia ka piʻi ʻana o ka BP.
Papa Hoʻohālikelike a me ka pakuhi (Summary)
ʻAno Haʻawina / ʻIkepili | Hopena / Ana | Waiwai / wehewehe |
---|---|---|
Māhele III (301+302 hui pū ʻia) | FSFI-D (kaulana makemake) | +0.35 vs placebo (P<0.001); FSDS-DAO −0.33 |
Nā Hana Hoʻopilikia | Nausea, ʻulaʻula, poʻo | Nausea ~ 30–40% (max ~ 40%); ka hoʻoulu ʻana ≥10%; poʻo poʻo ≥10% |
Ka manawa hoʻouna: Sep-30-2025