Millicent Pharma
Ireland - Dundalk
PharmaceuticalFocus: Menopausal Treatment
Millicent Pharma is a life sciences company focused on Menopausal Treatment.
Women's Health
Open Jobs
0
Products & Portfolio (3)
FEMLYV
norethindrone acetate/ethinyl estradiol
Growth
ORAL · TABLET, ORALLY DISINTEGRATING
ovulation.
pregnancy () Limitations of Use The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m has not been evaluated (
2024
0
FEMRING
estradiol acetate
LOE Approaching
VAGINAL · INSERT, EXTENDED RELEASE
characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
Moderate to Severe Vasomotor Symptoms due to Menopause ()Moderate to Severe VulvarVaginal Atrophy due to Menopause () 1
2003
30
INTRAROSA
prasterone
Peak
VAGINAL · INSERT
12.1 Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established. 12.3 Pharmacokinetics In a study conducted in postmenopausal women, administration of the INTRAROSA vaginal insert once daily for 7 days resulted in a mean prasterone C max and area under the curve from 0 to 24 hours (AUC 0-24 ) at Day 7 of 4.4 ng/mL and 56.2 ng·h/mL, respectively, which were significantly higher than those in the group treated with placebo (Table 1). The C max and AUC 0-24 of the metabolites testosterone and estradiol were also slightly higher in women treated with the INTRAROSA vaginal insert compared to those receiving placebo. Table 1. C max and AUC 0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± SD). N=8 Placebo (N=9) INTRAROSA (N=10) Prasterone C max (ng/mL) 1.60 (±0.95) 4.42 (±1.49) AUC 0-24 (ng·h/mL) 24.82 (±14.31) 56.17 (±28.27) Testosterone C max (ng/mL) 0.12 (±0.04) 0.15 (±0.05) AUC 0-24 (ng·h/mL) 2.58 (±0.94) 2.79 (±0.94) Estradiol C max (pg/mL) 3.33 (±1.31) 5.04 (±2.68) AUC 0-24 (pg·h/mL) 66.49 (±20.70) 96.93 (±52.06) Figure 1. Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or INTRAROSA (mean ± SD). In two primary efficacy trials, daily administration of INTRAROSA vaginal insert for 12 weeks increased mean serum C trough of prasterone and its metabolites testosterone and estradiol by 47%, 21% and 19% from baseline, respectively. This comparison based on C trough may underestimate the magnitude of increase in prasterone and metabolites' exposure because it does not take into account the overall concentration-time profile following administration of INTRAROSA. Metabolism Exogenous prasterone is metabolized in the same manner as endogenous prasterone. Human steroidogenic enzymes such as hydroxysteroid dehydrogenases, 5α-reductases and aromatases transform prasterone into androgens and estrogens. Figure 1
moderate to severe dyspareuniaa symptom of vulvarvaginal atrophy+1 more
2016
0
Open Jobs (0)
No open positions listed yet. Check their careers page directly.
Interview Prep Quick Facts
Portfolio: 3 approved products
Top TAs: Women's Health
Portfolio Health
Growth1 (33%)
Peak1 (33%)
LOE Approaching1 (33%)
3 total products