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

TherapeuticsMD, Inc. 8-K

TherapeuticsMD Announces FDA

Approval of TX-004HR: IMVEXXYTM (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

-IMVEXXY's applicator-free

self-administration was developed with the woman in mind-

-TherapeuticsMD will host a conference

call at 8:00 AM EDT today-

BOCA RATON, Fla.--(BUSINESS

WIRE)-May 30, 2018-TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company, today

announced that the United States Food and Drug Administration (FDA) has approved IMVEXXYTM (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 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.1 VVA is a chronic, progressive condition that leads to distressing symptoms and can progressively

worsen if not treated.2

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.2

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 1 out of 2 women will experience pain during intercourse due to VVA at some point during their lives.3

"Studies have shown that

many women are not seeking treatment for VVA and 81% are unaware that VVA is a treatable medical condition and part of a constellation

of symptoms associated with loss of estrogens," said Dr. Sheryl Kingsberg, President, North American Menopause Society. "I

am delighted that our patients will now have a convenient treatment option with IMVEXXY and hope that the excitement generated

by this new option will encourage women to talk to their healthcare provider and get relief from their pain and discomfort due

IMVEXXY For the Treatment of Moderate to Severe

Dyspareunia Due to Menopause

Imvexxy's mechanism of action

is the re-estrogenization of the tissue in and around the vagina. IMVEXXY's distinctive formulation ensures that it dissolves

completely without mess, so patients can use it any time of day by placing the softgel capsule in the lower part of the vagina

to treat the vulva and vagina. IMVEXXY is administered daily for two weeks followed by only twice a week dosing. Nine out of 10

patients who participated in a clinical trial reported that IMVEXXY was "easy to use."4

The FDA approval of IMVEXXY is

based on the results of a Phase 3, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of

IMVEXXY (4 mcg and 10 mcg) compared to placebo from baseline to week 12. The study showed that IMVEXXY provided relief of moderate

to severe dyspareunia due to menopause as early as week 2 for both doses.5 Statistically significant changes in vaginal

cytology and pH were also observed.5 A substudy of the REJOICE trial evaluated the pharmacokinetics

of IMVEXXY 4 mcg, 10 mcg, and placebo. With both the 4 mcg and 10 mcg doses, the mean concentration of estradiol and estrone remained

within average postmenopausal range.6 The results were published in the journal Menopause: The Journal of The North

American Menopause Society.5,6

The most common adverse reaction

with IMVEXXY (incidence 3 percent) and greater than placebo was headache. There were no clinically significant differences

in AEs observed between treatment and placebo groups.5 Important safety information for IMVEXXY, including the boxed

warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia, is provided below. The full prescribing

information may be viewed by visiting www.imvexxy.com.

TherapeuticsMD anticipates that IMVEXXY will be available

for commercial distribution in July.

As part of the FDA's approval,

TherapeuticsMD has committed to conduct a post-approval observational study.

Conference Call Information

TherapeuticsMD will host a conference call today to discuss

the IMVEXXY approval. Details for the call are:

Additionally, a live webcast can be

accessed on the company's website, www.therapeuticsmd.com, on the Home Page or under the "Investors & Media"

section. A digital recording of the conference call will be available for replay beginning two hours after the call's completion

and for at least 30 days with the dial-in (855) 859-2056 or international (404) 537-3406 and Conference ID: 4757309.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Please note that this information is not comprehensive.

Please visit www.imvexxy.com for the Full Prescribing Information, including the Boxed Warning.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an

innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA

technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical

hormones through a variety of dosage forms and administration routes. The company has recently received FDA approval for TX-004HR,

branded as IMVEXXY (estradiol vaginal inserts), for the treatment of moderate to severe dyspareunia, a symptom of vulvar

and vaginal atrophy, due to menopause. The company's late stage clinical pipeline includes TX-001HR for treatment of moderate-to-severe

vasomotor symptoms (VMS) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal

vitamins as well as over-the-counter prenatal vitamins under the vitaMedMD and BocaGreenMD brands.

Forward-Looking Statements

This press release by TherapeuticsMD,

Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating

to TherapeuticsMD's objectives, plans and strategies as well as statements, other than historical facts, that address activities,

events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These

statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates,"

"should," "intends," "plans," "will," "expects," "estimates,"

"projects," "positioned," "strategy" and similar expressions and are based on assumptions and

assessments made in light of management's experience and perception of historical trends, current conditions, expected future

developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the