"We are very pleased by this recognition among so many top-quality submissions. It is a testament to the dedication of our research team and a reflection of our commitment to develop innovative hormone therapies that fill the critical need for better treatments in the hormone and women’s health market. Using our technology to enable the delivery of body-identical hormones through a variety of dosage forms and administration routes, we hope to reverse what we believe has been a long-standing innovation gap in women’s health," said Robert Finizio, Co-Founder and Chief Executive Officer of TherapeuticsMD.
About the Study
The study, which was sponsored by TherapeuticsMD, Inc., was designed to determine the pharmacokinetics and bioavailability of its combination capsule of 17β-estradiol and progesterone (test drug: TX 12-001-HR). Participants included 66 healthy, postmenopausal women, age 40-65 years. Each participant was randomly assigned to begin one of three dosing sequences, each including three periods. During one period participants received a single dose of the test drug, and during two periods they received single doses of both the estradiol and progesterone reference drugs, which were taken concurrently. Blood samples were collected at multiple intervals, beginning one hour prior to start of dosing and continuing to 48 hours after dosing. Bioavailability was determined by measuring the rate and extent of absorption of the drugs.
About Hormone TherapyMenopausal hormone therapy (HT) is the administration of hormones to treat menopausal symptoms resulting from a lack of naturally occurring hormones. Current HT options include FDA-approved combination products, FDA-approved estrogen-only and progestogen-only products, and non-FDA approved compounded bioidentical products. A body-identical combination product, which exactly matches the molecular structure of the human hormones estradiol and progesterone, is being developed by TherapeuticsMD and is currently in phase 3 clinical trials. HT is projected to be the largest growth segment in the overall women’s health market. The potential market for pharmacy-compounded, bioidentical HT products is estimated to be approximately $1.5 billion per year.