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Courtesy: TherapeuticsMD
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An innovative, investigational combination of 17ß-estradiol and
progesterone in a single, oral softgel, was found effective for the treatment
of moderate to severe vasomotor symptoms (VMS) due to menopause. The results of
the study were presented at the ENDO 2017, the annual meeting of the Endocrine Society in Orlando, Florida, April 1-4.
TherapeuticsMD, Inc which specializes in developing women’s
health products has developed this combination drug named as TX-001HR. TherapeuticsMD
is using the unique technology called ‘SYMBODA’ in manufacturing the softgel
capsules. SYMBODA,
meaning “similar to the body,” is a solubilized female hormone technology for
formulation of estradiol and progesterone identical in chemical structure to
the estradiol and progesterone that women naturally produce.
Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. "There are currently no FDA-approved oral
bio-identical estradiol and progesterone combination products for women
experiencing hot flushes and night sweats. Approximately 1 million to 2.5
million women are currently estimated to use non-FDA-approved compounded
menopausal hormone therapy (CBHT) in the U.S.
TherapeuticsMD seeks to address
the unmet needs of post-menopausal women as we develop potentially the first
FDA-approved 17β-estradiol plus progesterone combination softgel capsule in the
United States."
If the drug gets approved by FDA, it represents first single
combined bioidentical estradiol and progesterone formulation in the market. Till
now bioidentical hormones are custom made at compounding pharmacies which are ‘not
regulated by FDA.’ Many women choose these because they think they are natural,
plant based, safer and do not have any side effects.
Many Societies like The Endocrine Society, the North American
Menopause Society, the American College of Obstetricians and Gynecologists
(ACOG) and the British Menopause Society have all raised concern regarding the
hazards of using custom-compounded hormones to treat menopausal symptoms.
The positive results of Replenish Trial, a phase 3 study that
evaluated the safety and efficacy of four doses of TX-001HR were presented at
the conference by Rogerio Lobo, M.D., professor of Obstetrics and Gynecology
and Director of the Reproductive Endocrinology Program at Columbia University.
Replenish trial is a prospective, randomized, double-blind,
placebo-controlled, parallel-group, multicenter study evaluating four doses of
TX-001HR with an objective of evaluating the drug’s effectiveness in relieving
hot flashes in post-menopausal women.
The study enrolled 1835 healthy women between 40−65 years with intact
uterus having ≥7/day or ≥50/week hot flushes. They were randomized to 5 groups
receiving either of this 4-dose combination of TX-001HR: E2/P 1.0 mg/100 mg; E2/P 0.5 mg/100 mg; E2/P
0.5/50; E2/P 0.25/50 or a placebo.
The efficacy of the drug was assessed by changes in number and intensity
of hot flushes while on drug at end of 1 and 3 months.
Another subset of women who did not fit the criteria for VMS
were randomized to receive either of the 4-dose combination of the drug to
evaluate endometrial hyperplasia. All women underwent biopsy at the start of
therapy and at the end of1 year. The safety end point was ≤1% incidence of
endometrial hyperplasia at end of 12 months.
The results showed that TX-001HR combinations of E2/P 1.0 mg/100
mg or 0.5 mg/100 mg was most effective in controlling VMS without any
unacceptable side effects.
Incidence of endometrial hyperplasia was 0%, with no reported
case of endometrial cancer with any of the dose combination at the end of 12
months which is unlike reported cases of endometrial hyperplasia with compounded
bio-identical hormone therapy (CBHT).
Dr Lobo concluded his talk saying “TX-001HR, "if
approved," would be a new oral hormone-therapy option for postmenopausal
women with moderate to severe vasomotor symptoms who have an intact uterus.
It may be a new option for the estimated millions of women
currently using less regulated and unapproved compounded bioidentical hormone
therapy."
The combination hormone pill Replenish Trial is the second
clinical trial completed by TherapeuticsMD, which last December announced
results from its Rejoice trial where it tested its softgel successfully in relieving vaginal dryness associated with menopause.
The 2 abstracts from the ENDO 17 conference can be accessed here:
Abstract 1 and Abstract 2.
