TherapeuticsMD is developing new products to treat diseases and conditions in key women’s healthcare categories, with a short-term pipeline focus on new and improved hormone replacement therapies. Three novel development programs are currently ongoing.

TX 12-001HR (estradiol + progesterone)
Menopause is a time in a woman’s life where the monthly cycle of estradiol building the uterine lining, ovarian egg release, and progesterone causing endometrial shedding and bleeding stops. It is due to the ovary ceasing production of estradiol and progesterone. TX 12-001HR is the first and only combination drug candidate designed to replace the exact 17ß-estradiol and progesterone hormones the body has stopped producing and to treat the symptoms of menopause due to the reduction of those hormones.

TX 12-001HR is a novel combination of 17ß-estradiol and progesterone that may provide a safer and more effective alternative compared to current hormone therapies. A safer product may be seen as a result of a better lipid and CV profiles for progesterone versus synthetic progestins and the potential of using lower effective doses due to a synergistic effect of both for vasomotor symptoms. A more effective candidate is a result of less variability and slightly higher bioavailability of the progesterone versus the reference listed drug.

TX 12-001HR has completed a pivotal PK study and is anticipating starting Phase 3 clinical trials in first half 2013.
TX 12-001HR is being developed via the 505(b)(2) regulatory pathway. This pathway avoids lengthy, costly and repetitive preclinical and clinical trials often associated with the 505(b)(1) regulatory pathway. In addition, we believe the 505(b)(2) route may have a more clearly defined timeline than other types of submissions.

TX 12-002HR (progesterone)
Amenorrhea is the absence of a menstrual period in a woman of reproductive age. Physiological states of amenorrhoea are seen during pregnancy and lactation (breastfeeding), the latter also forming the basis of a form of contraception known as the lactational amenorrhoea method. Amenorrhea is a symptom with many potential causes. Secondary amenorrhoea (menstruation cycles ceasing) is often caused by hormonal disturbances from the hypothalamus and the pituitary gland, from polycystic ovarian syndrome and premature menopause or intrauterine scar formation. It is defined as the absence of menses for three months in a woman with previously normal menstruation. TX 12-002HR is a progesterone product under development for the treatment of secondary amenorrhea. It is a natural progesterone formulation without the potentially allergenic component of peanut oil (as contained in currently available oral progesterone formulations). The product is chemically identical to the hormone that naturally occurs in a women’s body.

TX 12-002HR has completed a pivotal PK study and is anticipating starting Phase 3 clinical trials in 2013.
TX 12-002HR is being developed via the 505(b)(2) regulatory pathway.

TX 12-003HR (estradiol)
Menopause literally means the "end of monthly cycles", from the Greek word pausis (cessation) and the root men- (month). Menopause typically occurs in women during their late 40s or early 50s, and it signals the end of the fertile phase of a woman's life.

This transition from a reproductive to a non-reproductive state is the result of a reduction in female hormonal production by the ovaries. This transition is normally not sudden or abrupt, tends to occur over a period of years, and is a natural consequence of aging. However, for some women, the accompanying signs and effects that can occur during the menopause transition years can significantly disrupt their daily activities and sense of well-being.

Menopause can be officially declared (in an adult woman who is not pregnant, is not lactating, and who has an intact uterus) when there has been amenorrhea (absence of any menstruation) for one complete year. However, there are many signs and effects that lead to this point, many of which may extend well beyond the "official" declaration date of menopause. These include: irregular menses, vasomotor instability (hot flashes and night sweats), atrophy of genitourinary tissue, increased stress, breast tenderness, vaginal dryness, forgetfulness, mood changes, and in certain cases, osteoporosis and/or heart disease. These effects are related to the hormonal changes a woman's body is going through, and they affect each woman to a different extent.

TX 12-003HR is a 17B estradiol product under development in postmenopausal women for the treatment of moderate to severe vasomotor symptoms due to menopause. These symptoms include hot flashes, night sweats, sleep disturbances, and vaginal dryness.

TX 12-003HR has completed pilot PK studies.
TX 12-003HR is currently under review for the next clinical study phase.

TX 12-004HR (estradiol)
TX 12-004HR is a 17β estradiol product under development for treatment of postmenopausal women for vulvar and vaginal atrophy. It is a unique delivery design using a VagiCap™ softgel capsule technology to provide easy, simple delivery.

The product is currently in formulation development and will be moving to IND and Phase 1 clinical trials in 2013.
TX 12-004HR is being developed via the 505(b)(2) regulatory pathway.