TherapeuticsMD Announces FDA Approval of ANNOVERA (Segesterone Acetate/Ethinyl Estradiol Vaginal System) for Birth Control - The first and only birth control approved as a vaginal system - - The fir

TherapeuticsMD, Inc. 8-K

TherapeuticsMD Announces

FDA Approval of ANNOVERA (Segesterone Acetate/Ethinyl

Estradiol Vaginal System) for Birth Control

- The first and only birth control

approved as a vaginal system -

- The first and only patient-controlled,

procedure-free, long-acting, reversible prescription birth control product to provide a full year of protection from pregnancy

-TherapeuticsMD will host a conference

call on Monday, August 13th at 8:30 a.m. EDT-

RATON, Fla.-August 10, 2018-TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company,

today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved ANNOVERA

(segesterone acetate/ethinyl estradiol vaginal system), the first long-acting

prescription birth control that is patient-controlled, procedure-free and reversible. The ANNOVERA contraceptive vaginal system

is a small, soft flexible ring that prevents ovulation for an entire year (13 cycles) and can be inserted and removed by a woman

at her discretion in repeated four-week cycles (remaining in place continuously for three weeks followed by removal for one week).

The segesterone acetate component

of the ANNOVERA contraceptive vaginal system is expected to be classified as a "new chemical entity," or NCE, by the

FDA and thus will likely be entitled to five years of regulatory exclusivity under the Drug Price Competition and Patent Term Restoration

Act of 1984, otherwise known as the Hatch-Waxman Act. This unique contraceptive vaginal system technology combines low doses of

a novel progestin, Nestorone (segesterone acetate), with a widely used estrogen (ethinyl estradiol). The contraceptive

vaginal system works by releasing an average continuous daily dose of 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl

estradiol to prevent pregnancy.

"The U.S. contraceptive

market is shifting toward long-acting solutions and we believe ANNOVERA represents an exciting new entrant for women and healthcare

providers by providing the first woman-controlled, procedure-free, long-acting, reversible birth control product putting the woman

in control of both her fertility and menstruation," said Dr. Brian Bernick, Co-Founder of TherapeuticsMD. "We believe

ANNOVERA can help meet the needs of women who are looking for long-acting solutions, including women who have never given birth

and women who are not in a monogamous relationship, who are often counseled not to use many of the currently available long-acting

contraceptive products."

ANNOVERA was developed by the

global non-profit research organization, Population Council, a leading developer of long-acting, reversible contraceptives. The

FDA approval of ANNOVERA is based in part on data from 17 clinical trials, including safety and efficacy data from three open-label

trials that included 2,308 healthy women in total. The data showed that ANNOVERA was 97.3% effective in preventing pregnancy

when used as directed - making it among the most effective women-controlled methods of contraception. Based on pooled data

from the two trials of 2,111 females 35 years of age, the primary endpoint Pearl Index

(PI) was 2.98 per 100 woman-years of ANNOVERA use. Results from the Phase 3 acceptability sub-study of 905 women support an overall

satisfaction rate of 89%, which was related to ease of use, side effects, expulsions/feeling the product and effects during sexual

activity. The trials also demonstrated high rates of adherence and continuation for a full year.i The most common adverse

reactions leading to discontinuation by 1% of ANNOVERA-treated women included irregular bleeding (metrorrhagia/menorrhagia)

(1.7%), headache/migraine (1.3%), vaginal discharge/vulvovaginal mycotic infections (1.3%), and nausea/vomiting (1.2%). Consistent

with other combination hormonal contraceptives (CHCs), cigarette smoking increases the risk of serious cardiovascular events from

CHC use. Women over 35 years old who smoke should not use ANNOVERA. Also consistent with other CHCs, women are at increased risk

for a venous thrombotic event (VTE) when using the one-year contraceptive vaginal system. Limited data are available in women with

a Body Mass Index (BMI) greater than 29 kg/m2 because this population was excluded from the clinical trials after VTEs

were reported. A post-approval observational study will be performed to measure the risk of venous thromboembolism. Important safety

information for ANNOVERA, including the boxed warning, is provided below.

"ANNOVERA's approval

and designation as a vaginal system' potentially creates a new class of contraception that private health plans will

be required to cover with no patient out-of-pocket costs under the Affordable Care Act (ACA)," said Robert Finizio, TherapeuticsMD

CEO and Co-Founder. "TherapeuticsMD intends to leverage its existing infrastructure to commercialize ANNOVERA. Together with

our prescription menopausal hormone products and prenatal vitamins, TherapeuticsMD aims to become the premier women's healthcare

company, offering a full portfolio of products across the woman's lifespan from contraception and pregnancy through menopause."

U.S. market for prescription contraceptives generated more than $5 billion in net sales in 2017.ii An

estimated 43 million women in the U.S. are at risk of unintended pregnancy of which 18 million women want to avoid pregnancy and

nearly half of all pregnancies that occur each year in the U.S. are unintended.iii,iv According to the National Center

for Health and Statistics, use of long-acting reversible contraceptives increased nearly 5-fold in the last decade among women

intends to leverage the Population Council's existing relationships with the supplier of segesterone acetate and the manufacturer

of the clinical trial supply of the one-year contraceptive vaginal system to scale-up commercial manufacturing of ANNOVERA. TherapeuticsMD

currently estimates that ANNOVERA will be commercially available as early as the third quarter of 2019 with the commercial launch

as early as the fourth quarter of 2019 or first quarter of 2020. The ACA mandates that private health plans provide coverage with

no out-of-pocket costs for one treatment per class of in each of the classes identified by the FDA for women in its Birth Control

Guide. As part of its license agreement with the Population Council, TherapeuticsMD has agreed to provide significantly reduced

pricing to federally designated Title X family planning clinics serving lower-income women.

Conference Call Information

TherapeuticsMD will host a conference call to

discuss the ANNOVERA 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: 5239706.

ANNOVERA one-year contraceptive vaginal system combines a widely used estrogen (ethinyl estradiol) with a new progestin segesterone

acetate (Nestorone ) into a single ring to prevent ovulation for an entire year (13 cycles; used in repeated four-week

cycles (remaining in place continuously for three weeks followed by removal for one week)). Designed to empower women to be in

complete control of their fertility and menstruation, ANNOVERA represents the first and only long-acting birth control product

that is reversible and does not require a medical procedure for insertion or removal. The soft, flexible ring can be inserted

and removed by the woman herself and without the help of a healthcare professional. The one-year vaginal system represents

a new option for women, including nulliparous women (women who have not given birth) desiring long-acting reversible contraception.

The one-year contraceptive vaginal system does not require refrigeration.

ANNOVERA is a progestin/estrogen

CHC indicated for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in

females with a BMI of > 29 kg/m2).

Important Safety Information

Cigarette smoking increases

the risk of cardiovascular events from CHC use. This risk increases with age, particularly in females over 35 years of age, and

with the number of cigarettes smoked. CHCs should not be used by females who are over 35 years of age and smoke.

Due to increased risks of serious

side effects, ANNOVERA should not be used in females with certain medical conditions, including females who have a high risk of

arterial or venous thrombotic diseases; who have or have had breast cancer or other estrogen- or progestin-sensitive cancer; who

have liver tumors, acute hepatitis, severe cirrhosis, undiagnosed abnormal uterine bleeding, or hypersensitivity to any ingredients

in ANNOVERA; who use certain Hepatitis C drug combinations; or who are pregnant or breastfeeding.

Risks from use of a CHC, like

ANNOVERA, particularly in females with any condition listed above, include venous thrombotic events; cardiovascular events and

cerebrovascular events such as stroke and myocardial infarction; liver disease; elevated liver enzymes with concomitant Hepatitis

C treatment; hypertension; carbohydrate and lipid metabolic effects; headache; bleeding irregularities and amenorrhea.

ANNOVERA does not protect against

HIV-infection (AIDS) and other sexually transmitted infections.

Please note that this information

is not comprehensive. Please see the Full Prescribing Information, including the Boxed Warning, for ANNOVERA at www.annovera.com/pi.pdf.