Donesta C302 Study Safety data - Top level conclusions:
(info van de Webcast)
Donesta's overall safety profile confirmed (consistent with previous studies of E4)
No safety issues, no drug related life-threatening events or deaths.
In hysterectomized women: Donesta at a dose of 15mg or 20mg per day is well tolerated
In non-hysterectomized women: as expected for an estrogen administered alone, endometrial-related events were observed
(vaginal hemorrhage, vaginal bleeding, uterine bleeding, endomletrial biopsy findings, no caces of carcinoma)
> Once the estrogen was first administered and followed by the administeration of progesterone, endometrial thickening was,
partially to completely, reversed within a two-week treatment.
> As expected, the addition of a progestin will be needed to curb endometrial proliferation.
Adverse Events (AEs)
- Vast majority of AE are mild or moderate in severity (<= 5% severe AEs)
- Hysterectomized women: bret tenderness and nipple pain
- Non-hysterectomized women: vaginal/uterine bleeding, breast tenderness, endomitrial biopsy
related AEs, endometrial thickening, abdominal pain and nipple pain
- E4 has a positive influence on Bone turnover (measured by biomarkers CTX1 and P1NP)
- Beneficial effect on Cholesterol profile.
- Minimal change of Hemostasis and hepatic markers.
Pre-Submission Meeting FDA: Q2 2023
NDA filing FDA end of June 2023