Bijuva (estradiol/progesterone) / TherapeuticsMD, Knight Therap - LARVOL DELTA

Cosette Pharmaceuticals Announces Acquisition of Mayne Pharma, Transforming Company into a Leader in Women’s Health and Dermatology (Businesswire) - "Cosette Pharmaceuticals...announced today that it has entered into a definitive agreement to acquire all the outstanding shares of Mayne Pharma Group Limited (ASX: Ticker MYX) (Mayne Pharma) at AUD$7.40/share for a total consideration of approximately USD $430 Million. The Boards of Directors of both companies have approved the transaction and Mayne Pharma’s Board of Directors has unanimously recommended that its shareholders vote in favor of the transaction. The transaction is expected to close in the second quarter of 2025....Upon close, Cosette will market 12 patent-protected products focused on women’s health and dermatology, including leading brands such as VYLEESI, INTRAROSA, NEXTSTELLIS, ANNOVERA, BIJUVA, IMVEXXY and RHOFADE, and several programs in clinical development."

M&A • Dermatology • Women's Health

The effect of ovariectomy, 17β-estradiol treatment, and progesterone treatment on dopaminergic regulation of prepulse inhibition in adult and adolescent female mice. (PubMed, Horm Behav) - "Either in adulthood (11 weeks of age) or adolescence (5 weeks of age), female mice underwent ovariectomy (OVX) and were implanted with 17β-estradiol, progesterone, or a combination of these hormones. This role may develop during adolescence as similar effects of OVX and ovarian hormones were not observed following interventions in 5-week old mice. Our results also confirm and extend previous evidence that 17β-estradiol may have antipsychotic properties."

Journal • Preclinical • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

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

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LncRNA STAT3-AS regulates endometrial receptivity via the STAT3 signaling pathway. (PubMed, Theriogenology) - "STAT3-AS expression was upregulated in gEECs treated with IFNT alone or in combination with progesterone and estradiol...However, pretreatment with the STAT3 activator RO8191 restored the effect of silencing STAT3-AS on endometrial receptivity. Overall, these results suggest that STAT3-AS is an important regulator of endometrial receptivity in goats and that it regulates endometrial receptivity through the STAT3 pathway."

Journal • ITGB3

Addition of progesterone to feminizing gender-affirming hormone therapy in transgender individuals for breast development: a randomized controlled trial. (PubMed, BMC Pharmacol Toxicol) - P2 | "This study will indicate whether progesterone is safe and of additional value with regard to breast volume change in transgender individuals receiving feminizing GAHT. The results of this study will be useful for innovation of feminizing GAHT."

Journal • Aesthetic Medicine

The inhibitory effect of trastuzumab on BT474 triple‑positive breast cancer cell viability is reversed by the combination of progesterone and estradiol. (PubMed, Oncol Lett) - "Breast cancer expressing the estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2) is known as triple-positive (TPBC). Notably, in most of the experiments, RU486 did not antagonize the effects of Pg. In conclusion, Pg and E2 may interfere with the inhibitory effect of TTZ on cell viability through PR-B activation and PR-A inactivation."

Journal • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CCND1 • CDK4 • ER • HER-2 • PGR

Spinal dopaminergic D-and D-like receptors have a sex-dependent effect in an experimental model of fibromyalgia. (PubMed, Eur J Pharmacol) - "Combination 17β-estradiol/progesterone, but not 17β-estradiol nor progesterone alone, restored the antiallodynic effect of pramipexole and quinpirole in the rats. Mifepristone (progesterone receptor antagonist) abated 17β-estradiol + progesterone restoration of antiallodynic effect of pramipexole and quinpirole. These data suggest that the antiallodynic effect of dopamine D-and D-like receptors in fibromyalgia-type pain depends on spinal 17β-estradiol/estrogen receptor-α and progesterone receptors, respectively."

Journal • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Effects of Atractylodes Macrocephala Rhizoma polysaccharide on intestinal microbiota composition in rats with mammary gland hyperplasia. (PubMed, Front Endocrinol (Lausanne)) - "MGH rat models were established by estradiol-progesterone combination and treated with AMP gastric infusion...AMP has good therapeutic effects on MGH rats, decreasing estradiol (E) and prolactin (PRL) levels and increasing progesterone (P) levels; at the same time, it can regulate the abundance and diversity of intestinal flora of MGH rats, improve the disorder of intestinal flora caused by MGH, and change the community structure, increase the abundance of beneficial flora, and decrease the abundance of pathogenic flora. AMP can improve the intestinal microbiological environment of MGH rats, maintain the microecological balance of intestinal microbial, and improve MGH symptoms."

Journal • Preclinical • Endocrine Disorders • Gastrointestinal Disorder • PRL

Systematic selection of Impurities, Development, and Validation of Related Substance Methods for Estradiol and Progesterone in a Combination Drug Product. (PubMed, J AOAC Int) - "In order to quantify the associated impurities of both actives in the presence of a highly complex matrix, the performance of the HPLC approach considerably possesses a higher degree of selectivity."

Journal

Modulation of morphine physical dependence and discriminative stimulus effects by ovarian hormones: Role of estradiol. (PubMed, Pharmacol Biochem Behav) - "Acute administration of estradiol, but not progesterone or a combination of estradiol and progesterone, significantly reduced naloxone-precipitated weight loss in morphine-dependent rats. These data indicate that estradiol influences the behavioral effects of morphine, possibly by increasing endogenous tone at mu opioid receptors."

Journal • Addiction (Opioid and Alcohol)

Position Statement by Experts of the Polish Menopause and Andropause Society on menopausal hormone therapy with an oral combination drug containing oestradiol 1 mg and progesterone 100 mg. (PubMed, Prz Menopauzalny) - "At a meeting held on 20 May 2021, reviewed the available literature on the use of the medicinal product Bijuva® for the relief of menopausal symptoms."

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"EU & UK Conclude Decentralised Procedure Approval for Bijuva® (Estradiol & Progesterone) Capsules for Hormone Replacement Therapy https://t.co/KQfnDr9SkT" (@NewsFromBW)

Bioidentical Oral 17β-Estradiol and Progesterone for the Treatment of Moderate to Severe Vasomotor Symptoms of Menopause. (PubMed, Ann Pharmacother) - "17β-E/P is a novel bioidentical product that is the first of its kind in the treatment of moderate to severe menopausal symptoms."

Journal

[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

Knight and TherapeuticsMD Announce Health Canada Approval of BIJUVA (Businesswire) - "Knight Therapeutics...and TherapeuticsMD...announced today the approval of BIJUVA® (estradiol and progesterone) capsules by Health Canada. In Canada, BIJUVA is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women with an intact uterus. VMS are commonly known as hot flashes or flushes and night sweats. VMS affect 60% to 80% of women entering menopause."

Canadian regulatory • Women's Health

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."

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