2018年5月30日，Therapeutics MD表示，美国食品和药物管理局已批准其激素疗法;estradiol（商品名 Imvexxy）用于治疗更年期引发的疼痛症状。该雌激素药物Imvexxy可用于治疗外阴和阴道萎缩，这是一种由绝经后女性荷尔蒙雌激素减少引起的疾病。
药物标签上的安全警告指出了对子宫内膜癌，心血管疾病，乳腺癌和潜在痴呆的风险。

TherapeuticsMD Announces FDA Approval of TX-004HR: IMVEXXY (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, Due to Menopause

BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
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. 

"IMVEXXY is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market," said Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD. "IMVEXXY is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional clean-up, and can be used anytime of day. It allows women the freedom to immediately return to their normal daily activities. Studies showed that, in patients who used IMVEXXY, systemic absorption of estradiol remained within postmenopausal range." 

"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," said Robert Finizio, Chief Executive Officer of TherapeuticsMD. "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." 

About Dyspareunia and Vulvar and Vaginal Atrophy (VVA)

VVA is a component of genitourinary syndrome of menopause (GSM), which may include, but is not limited to, genital symptoms of dryness, burning and irritation, sexual symptoms such as decreased lubrication, discomfort, and pain, and urinary symptoms such as urgency, dysuria, and recurrent urinary tract infections. VVA is a chronic, progressive condition that leads to distressing symptoms and can progressively worsen if not treated.

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.

VVA affects an estimated 32 million postmenopausal women in the US. Only about seven percent (2.3 million) of these women receive prescription treatment.3 Nearly out of 2 women will experience pain during intercourse due to VVA at some point during their lives.