TherapeuticsMD, Inc. (NASDAQ: TXMD) ran out of momentum Wednesday, after the company reported Food and Drug Administation approval of TX-004HR: IMVEXXY (estradiol vaginal inserts) for moderate to severe dyspareunia due to menopause.
The company, based in Boca Raton, Florida, boasts that IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available.
According to CEO Robert Finizio, “We are excited to bring IMVEXXY to market as TherapeuticsMD's first FDA-approved drug as we strive to be the premier Women's Health Company,"
"IMVEXXY reflects our long-standing corporate mission and commitment to health solutions that women want, based on the concepts of medical need, efficacy, safety, simplicity, and affordability. IMVEXXY will be offered at a price in parity with other products that have been on the market for 10 to 30 years. By ensuring patients can access IMVEXXY at an affordable price, TherapeuticsMD is doing the right thing for women.
VVA is a condition that develops when the body makes less estrogen due to menopause. Without sufficient estrogen, the vaginal tissue becomes thin, dry, and less elastic. The vaginal canal can also narrow and shorten. Insufficient estrogen can also decrease vaginal fluids, change the acid balance of the vagina, and weaken pelvic floor muscles. All these factors can lead to dyspareunia.
It affects an estimated 32 million postmenopausal women in the US. Only about 7% (2.3 million) of these women receive prescription treatment
Shares in the company fell 38 cents, or 5.9%, to $6.05.
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