It is estimated that between 80 and 200 million women in the U.S. suffer from sexual pain, which in most cases results in loss of sexual arousal, difficulty achieving satisfying orgasms and low sexual desire. This presents a problem for both these women and their partners. The problem is most acute among postmenopausal women; about 20 million of which report painful sex. Nine out of ten postmenopausal women with sexual pain choose not to use estrogens.
GTO Pharma, LLC is a New York–based drug development company. Since 2014, GTO has focused its efforts on developing a safe and efficacious topical treatment for certain painful female sexual disorders including vestibulodynia and dyspareunia which constitute the main causes of sexual pain. The result of this effort has been the development, testing and patenting of several non-hormonal compound formulations which effectively treat these conditions and provide other sexual health benefits such as sexual arousal, lubrication, and intensity of orgasm, thus leading to a fuller and more satisfying sexual life and well-being.
The GTO compounds are based on a sinecatechins ointment which is a previously approved FDA botanical drug for a different indication that has Phase IV safety data, and does not affect reproductive function. Moreover, this drug has been used for over 20 years by tens of thousands of patients
GTO compounds are safe and effective alternatives to, or may be prescribed in combination with, estrogens or other hormones used to treat genitourinary syndrome of menopause. GTO compounds are safe for women for whom estrogens are contraindicated. In premenopausal women, GTO compounds can safely be used in conjunction with birth control medications. The treatment regimen is a topical application and may be used “as needed” or on a periodic basis and is suitable for use by women 18 and over, particularly those afflicted with vestibulodynia.
In GTO’s clinical testing, the sinecatechin-based compounds, when topically applied, were markedly effective in either alleviating or eliminating vestibulodynia as a cause of sexual pain, with the added benefits of increasing overall sexual function, including increasing lubrication, arousal and orgasmic intensity.
GTO seeks a partner possessing the resources necessary to bring the GTO compounds to market as a prescription-based drug for a novel indication in the treatment of female sexual pain, (vestibulodynia) and to improve and enhance sexual function by increasing arousal, lubrication and orgasmic response. GTO is flexible in terms of the form of relationship and associated transaction that it is willing to consider.
Inquiries to: Wendy A. Epstein, M.D., F.A.A.D. 845-641-8661 firstname.lastname@example.org
SOME BASIC FACTS
- In a 1,500-woman study of routine gynecology patients more than 90% of respondents reported one or more sexual concerns:
- 87.2% reported hypoactive sexual desire
- 83.3% reported orgasmic disorders
- 74.7% reported decreased sexual arousal and difficulty in lubrication
- 7% reported sexual pain including dyspareunia
- 80-200 million women in the US suffer from sexual pain
- 46-130 million women suffer from vulvodynia at a treatment cost of $31-$72 billion annually.
- 20 million postmenopausal women in the US suffer from dyspareunia (painful sex) with a potential treatment market of ~$15 billion
- In the U.S. in 2017, 18 million out of 20 million postmenopausal women with dyspareunia DID NOT use hormonal treatments for sexual pain.
- Between 17% and 45% of postmenopausal women say they find penetrative sex painful.
- Up to 95% of postmenopausal women who experienced pain with penetration also had localized provoked pain in the vulvar vestibule despite the use of hormone supplements in 31% of patients
- Total market size is hard to pinpoint exactly, but thanks to safety profile of sinecatechins ointment, the entire >18-year-old population is eligible for the treatment.
BIO OF WENDY EPSTEIN, M.D., F.A.A.D.
Wendy Epstein is a board-certified physician, researcher and inventor. She is Principal and Chief Medical Officer of GTO Pharma, LLC., a practicing dermatologist, and a faculty member of NYU School of Medicine’s Department of Dermatology for the last 34 years. For 27 of those years she worked weekly in Bellevue Medical Center’s Dermatology Clinic treating a broad range of dermatological conditions, including vulvar dermatology. She discovered and patented a novel use for an FDA approved topical drug for female sexual disorders.
- B.A., Barnard College
- Master’s in Biology from Princeton University
- M.D. from Columbia Physicians & Surgeons Medical School
- NYU Medical School Dermatology Residency and Internal Medicine Internship
- Clinical Faculty NYU School of Medicine 1987 to Present
- Board Certified, American Academy of Dermatology
- Former Faculty Member, Yale School of Medicine Dermatology
- Member, North American Menopause Society (NAMS)
- Member, National Vulvodynia Association (NVA)
- Member, International Society for the Study of Women’s Sexual Health (ISSWSH)
- Member, International Society for Sexual Medicine (ISSM)
- Television and Radio appearances discussing various topics in dermatology
- Numerous publications in medical journals and books
- Clinical Consultant for Avon Products for 20+ years