SCE-A (synthetic conjugated estrogens-A vaginal cream) / Teva - LARVOL DELTA

[VIRTUAL] REPLENISH Trial: Endometrial Protection with a 17β-Estradiol and Progesterone Combination (TX-001HR) in Postmenopausal Women with Vasomotor Symptoms (ISGE-I 2020) - P3 | "Introduction: TX-001HR (approved as Bijuva® in the US, TherapeuticsMD, Inc., Boca Raton, FL) is a hormone therapy (HT) of combined naturally occurring 17β-estradiol and progesterone (which some call bio-identical) in a single, oral softgel capsule developed to treat menopause-related vasomotor symptoms (VMS). TX-001HR had a safe endometrial profile in postmenopausal women seeking relief for VMS. No endometrial hyperplasia or malignancy, or unexpected safety issues were observed, which is in contrast to what has been reported with compounded BHT. If approved, TX-001HR may be an alternative option of naturally occurring estradiol and progesterone that can be used to treat hot flushes for the estimated millions of postmenopausal women currently using unregulated, unapproved, compounded BHT, whose efficacy and safety have not been studied in rigorous clinical trials."

Clinical • Endometrial Cancer • Oncology • Solid Tumor • Women's Health

[VIRTUAL] REPLENISH trial: TX-001HR (17β-Estradiol and Progesterone Combination) Significantly Improved Moderate to Severe Hot Flushes in Postmenopausal Women (ISGE-I 2020) - P3 | "Introduction: TX-001HR (approved as Bijuva® in the US, TherapeuticsMD, Inc., Boca Raton, FL) is a hormone therapy (HT) of naturally occurring 17β-estradiol combined with progesterone (which some call bio-identical) in a single, oral softgel capsule developed to treat menopausal vasomotor symptoms (VMS). TX-001HR 1.0 mg/100 mg or 0.5 mg/100 mg effectively treated menopause-related moderate to severe hot flushes. If approved, TX-001HR – the first combination HT product containing naturally occurring 17β-estradiol and progesterone – may provide an alternative option for the estimated millions of women currently using unregulated, unapproved, compounded bio-identical HT."

Clinical

Drugs for menopausal symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial. (PubMed, Menopause) - P3 | "Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4 1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus."

Journal

"Knight and TherapeuticsMD Announce Filing of New Drug Submission for BIJUVA® in Canada https://t.co/iSwQwb7lot" (@NewsFromBW)

Estradiol/progesterone (Bijuva) for menopausal vasomotor symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal

Colorectal cancer screening. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal

Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms. (PubMed, JAMA) - No abstract available.

Journal

"As seen in @JAMA_current - Estradiol/Progesterone (Bijuva) for Menopausal Vasomotor Symptoms https://t.co/KaFGsUwcEm" (@MedicalLetter)

A Combined, Bioidentical, Oral, 17β-Estradiol and Progesterone Capsule for the Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. (PubMed, Expert Rev Clin Pharmacol) - P3; "TX-001HR was well tolerated and had no clinically significant impact on vital signs, metabolic or coagulation parameters, or breast safety. The combination bioidentical E2/P4 capsule (1 mg/100 mg dose was FDA-approved as Bijuva in October 2018) may provide a safe, effective, rigorously studied alternative for women with a uterus who prefer CHT for relief of VMS."

Journal

Addendum: estradiol/progesterone (Bijuva) for menopausal vasomotor symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal

Uterine bleeding rates with hormone therapies in menopausal women with vasomotor symptoms (EMAS 2019) - P3; " Bleeding data were identified for Bijuva (E2/P4 [mg/mg] 1/100), Prempro ® (CEE/MPA [mg/mg] 0.625/5; 0.625/2.5; 0.45/1.5; 0.3/1.5), Activella ® (E2/NETA [mg/mg] 1/0.5; 0.5/0.1) Angeliq ® (E2/DRSP [mg/mg] 1/0.5), Climara Pro ® (E2/LNG [mg/mg] 0.045/0.015) and CombiPatch ® (E2/NETA [mg/mg] 0.05/0.14; 0.05/0.25). Comparing amenorrhea rates over time of E2/P4 from REPLENISH with those reported in published product information for other HT with synthetic progestins in separate studies, using different methodologies, suggests a potentially improved bleeding profile with E2/P4. Endometrial bleeding incidence with CHT products (other than in one survey) has not been published, even though many women choose to use them to treat their VMS."

Clinical

Effects of estradiol and progesterone on sleep disturbance using mediation modeling (EMAS 2019) - P3; "The oral 1 mg 17β-estradiol/100 mg progesterone (E2/P4) softgel capsule (Bijuva TM ; TherapeuticsMD, Boca Raton, FL) was shown in REPLENISH to reduce moderate to severe hot flush (HF) frequency and severity and improve quality of life outcomes in postmenopausal women with a uterus, while protecting the endometrium. In REPLENISH, mediation modeling showed that E2/P4 improved sleep disturbances indirectly through improvements in HF symptoms and decreases in HF botherness (as measured by MENQOL). In women with moderate to severe VMS, oral E2/P4 capsules may also improve sleep."

"TherapeuticsMD to offer Bijuva https://t.co/2fEBf8IWqW" (@womens_womens)

"$TXMD Announces Commercial Availability of BIJUVA in the U.S." (@BioStocks)

Predictors Of Vaginal/Uterine Bleeding With Oral TX-001HR (Estradiol and Progesterone) Capsules Taken For Menopausal Vasomotor Symptoms (ENDO 2019) - P3; "...Cumulative amenorrhea rates (no bleeding or spotting for 13 cycles) ranging from 23% to 49% with current HT options1-3 are relatively lower than the 56% to 73% observed in the REPLENISH trial.4 The REPLENISH trial (NCT01942668) was a 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter trial that evaluated TX-001HR (bioidentical 17β-estradiol and progesterone [E2/P4] combined in a single, oral softgel capsule; 1 mg E2/100 mg P4 FDA approved as BIJUVATM; TherapeuticsMD, Boca Raton, FL) vs placebo in 1835 menopausal women (40−65 y; intact uterus) for the treatment of menopausal, moderate to severe vasomotor symptoms (VMS)...Prempro tablets PI...Activella tablets PI...Angeliq Tablets PI...Obstet Gynecol. 2018;132:161-170."

Predictors Of Vaginal/Uterine Bleeding With Oral TX-001HR (Estradiol and Progesterone) Capsules Taken For Menopausal Vasomotor Symptoms (ENDO 2019) - P3; "...Cumulative amenorrhea rates (no bleeding or spotting for 13 cycles) ranging from 23% to 49% with current HT options1-3 are relatively lower than the 56% to 73% observed in the REPLENISH trial.4 The REPLENISH trial (NCT01942668) was a 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter trial that evaluated TX-001HR (bioidentical 17β-estradiol and progesterone [E2/P4] combined in a single, oral softgel capsule; 1 mg E2/100 mg P4 FDA approved as BIJUVATM; TherapeuticsMD, Boca Raton, FL) vs placebo in 1835 menopausal women (40−65 y; intact uterus) for the treatment of menopausal, moderate to severe vasomotor symptoms (VMS)...Prempro tablets PI...Activella tablets PI...Angeliq Tablets PI...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and Sweating (ENDO 2019) - P3; "The objective of this analysis was to further determine the effects of the E2/P4 capsules versus placebo on vasomotor symptoms (VMS) as assessed by the menopause-specific quality of life (MENQOL) questionnaire.In the REPLENISH trial (NCT01942668), women with moderate to severe hot flushes (≥7/day or ≥50/week) were randomized 1:1:1:1:1 to daily E2/P4 (mg/mg) of 1/100 (FDA approved as BIJUVATM), 0.5/100, 0.5/50, 0.25/50, or placebo (VMS substudy). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor Symptoms (ENDO 2019) - P3; "In the REPLENISH trial, the oral 17β-estradiol/progesterone (E2/P4) softgel capsule (TX-001HR; 1 mg E2/100 mg P4 FDA approved as BIJUVATM; TherapeuticsMD, Boca Raton, FL), was shown to reduce moderate to severe hot flush frequency and severity and improve quality of life outcomes in menopausal women with a uterus, while protecting the endometrium. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Clinical

Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH Trial (ENDO 2019) - P3; "The 1 mg E2/100 mg P4 dose is FDA approved as BIJUVATM (TherapeuticsMD, Boca Raton, FL). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Late-breaking abstract

Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH Trial (ENDO 2019) - P3; "The 1 mg E2/100 mg P4 dose is FDA approved as BIJUVATM (TherapeuticsMD, Boca Raton, FL). Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and Sweating (ENDO 2019) - P3; "The objective of this analysis was to further determine the effects of the E2/P4 capsules versus placebo on vasomotor symptoms (VMS) as assessed by the menopause-specific quality of life (MENQOL) questionnaire.In the REPLENISH trial (NCT01942668), women with moderate to severe hot flushes (≥7/day or ≥50/week) were randomized 1:1:1:1:1 to daily E2/P4 (mg/mg) of 1/100 (FDA approved as BIJUVATM), 0.5/100, 0.5/50, 0.25/50, or placebo (VMS substudy). Benefits continued for up to 12 months of treatment. These Results with this first oral hormone therapy formulation combining bioidentical estradiol and progesterone in a single capsule are consistent with the primary REPLENISH Results demonstrating efficacy for the treatment of moderate to severe vasomotor symptoms in menopausal women with a uterus."

Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor Symptoms (ENDO 2019) - P3; "In the REPLENISH trial, the oral 17β-estradiol/progesterone (E2/P4) softgel capsule (TX-001HR; 1 mg E2/100 mg P4 FDA approved as BIJUVATM; TherapeuticsMD, Boca Raton, FL), was shown to reduce moderate to severe hot flush frequency and severity and improve quality of life outcomes in menopausal women with a uterus, while protecting the endometrium. In women 55+ years, significant improvements from baseline were observed at week 12 with three E2/P4 doses (1/100, 0.5/100, 0.5/50) vs placebo.In REPLENISH, women treated with E2/P4 capsules containing 1 or 0.5 mg E2 demonstrated significant and sustained improvements in the MENQOL difficulty sleeping assessment, especially those <55 years. These data warrant further evaluation."

Clinical