Fa'ailoga (fa'atagaina le fa'aoga): I le 2019, na fa'amaonia ai e le FDA mo le togafitia o le maua, fa'apena lautele fa'aletonu mana'oga fa'afeusuaiga (HSDD) i fafine a'o le'i fa'ata'ita'iina pe a o'o mai le fa'afitauli ma e le mafua mai i isi tulaga fa'afoma'i/mafaufau po'o a'afiaga o vaila'au.
Mechanism of Action
O le PT-141 o le melanocortin receptor agonist (fa'apitoa MC4 receptor) lea e fa'aogaina ai tu'inanau fa'afeusuaiga e ala i ala o le tino.
E le pei o le PDE5 inhibitors (faʻataʻitaʻiga, sildenafil), lea e masani ona aʻafia ai toto toto, o le PT-141 e galue faʻatotonugalemu e aʻafia ai lagona faʻafeusuaiga ma faʻamalosi.
Pharmacology & Dosing
Fa'atonuga: tui i lalo o le pa'u, pe a mana'omia (i luga ole mana'oga).
Fuafuaga fa'amaonia: 1.75 mg sc
Pharmacokinetics:
Tmax ≈ ~60 minute
t½ ≈ 2–3 itula
O aʻafiaga e mafai ona umi itula, i nisi lipoti e oʻo atu i le ~ 16 itula.
Lelei Fa'afoma'i (Vaega III Tofotofoga - TOE FA'AFE, 24 vaiaso, RCTs)
Fa'ai'uga autu:
Fa'asinomaga o Galuega Fa'afeusuaiga Fa'afa'afafine–Itu'āiga Mana'oga (FSFI-D)
Fua o Fa'afitauli Fa'afeusuaiga Fa'afafine (FSDS-DAO)
I'uga autu (su'esu'ega tu'ufa'atasi 301 + 302):
Fa'aleleia atili o le FSFI-D: +0.35 vs placebo (P<0.001)
Fa'aitiitia sikoa FSDS-DAO: −0.33 vs placebo (P<0.001)
O isi fa'ai'uga: O taunu'uga lagolago (fa'ailoga o galuega fa'afeusuaiga, fa'amalieina lipoti a le ma'i) na fa'aalia lelei, ae o mea fa'amalieina fa'afeusuaiga (SSEs) e le'i fa'aalia i taimi uma ni eseesega taua.
Tulaga Leaga (sili ona lipotia soo i tofotofoga)
Masani (≥10%):
Nausea (~ 30–40%; e oʻo atu i le ~ 40% lipotia i faʻataʻitaʻiga)
Fufulu (≥10%)
tiga ulu (≥10%)
A'afiaga ile cardiovascular:
Na matauina le si'itia le tumau o le toto ma suiga o le fatu, e masani lava ona foia i totonu o ni nai itula.
Faʻasaʻo pe faʻaaogaina ma le faʻaeteete i tagata gasegase e le pulea le toto maualuga poʻo le maʻi cardiovascular.
Ate: Lipoti e seasea maua i luga ole enzyme ole ate; O lipoti e matua'i seasea ona tupu e fa'ailoa mai ai e ono manu'a tu'i le ate, ae e le masani ai.
Saogalemu Tumau (Su'esu'ega Fa'aopoopo)
O le 52-vaiaso su'esu'ega fa'alautele igoa na maua ai le fa'aleleia atili o le mana'o e aunoa ma ni fa'ailoga fou o le saogalemu.
Fa'ata'ita'iga saogalemu mo taimi umi e manatu e masani ona fa'apalepaleina, ma o fa'afitauli autu fa'apalepale o lo'o iai pea a'afiaga leaga mo taimi pupuu e pei o le faufau.
Fa'amatalaga Fa'aoga Autu
E fa'atapula'aina le faitau aofa'i o tagata: Na'o tama'ita'i e le'i fa'ata'ita'i male fa'ata'ita'iga ua maua, HSDD lautele.
E le faʻatagaina lautele mo alii (ED poʻo le manaʻo maualalo i tama e tumau suʻesuʻega).
E taua tele le su'esu'eina o le saogalemu: O le toto maualuga, ma'i fatu fatu, ma le tala'aga o le ate e tatau ona su'esu'eina a'o le'i faia le talavai.
Aotelega Fa'amatalaga vave
FDA Faamaonia: 2019 (Vyleesi).
Fuafuaga: 1.75 mg tui i lalo o le paʻu, pe a manaʻomia.
PK: Tmax ~60 min; t½ 2–3 h; aafiaga e oo atu i le ~16 h.
Lelei (Vaega III, tuufaatasia):
FSFI-D: +0.35 (P<.001)
FSDS-DAO: −0.33 (P<.001)
Fa'alavelave fa'alavelave:
Nausea: e oo atu i le ~40%
Fufulu: ≥10%
Tiga ulu: ≥10%
Fa'amauina le si'itia ole BP ole taimi.
Laupapa Fa'atusatusa ma Kalafi (A'oa'oga)
Su'esu'ega / Ituaiga Fa'amatalaga | Fa'ai'uga / Fua | Taua/Fa'amatalaga |
---|---|---|
Vaega III (301+302 fa'atasi) | FSFI-D (ituaiga manaoga) | +0.35 vs placebo (P<0.001); FSDS-DAO −0.33 |
Mea Leaga | Faivale, fufula, ulu | Nausea ~ 30–40% (max ~ 40%); fufuluina ≥10%; ulu tiga ≥10% |
Taimi meli: Sep-30-2025