Now More Hope for Menopausal Women Experiencing the Physical and Emotional Impact of Painful Sex and Vaginal Dryness

New clinical data released on Prasterone (DHEA) Vaginal Ovules' positive effect on moderate to severe dyspareunia (Painful sex due to menopause) and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.

Quebec, Canada, January 06, 2016 --( Endoceutics, a private North American biopharma company, announced today the positive results of a pivotal phase 3 clinical trial just recently published online in Menopause: The Journal of The North American Menopause Society. The objectives of the study was to confirm the local beneficial effects of intravaginal Prasterone on moderate to severe dyspareunia or pain during sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM). The results demonstrated that daily intravaginal administration of Prasterone shown clinically and highly statistically significant improvements on the four co-primary parameters: pain at sexual activity (dyspareunia), percentage of parabasal cells, percentage of superficial cells and vaginal pH (markers for restoring a more health vaginal environment, similar to a pre-menopausal vaginal environment). In addition the strictly local action of Prasterone is in line with the absence of drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment.

Dr. David Archer, Director of the Clinical Research Center and Professor at Jones Institute of Reproductive Health at Eastern Virginia Medical Center and principle investigator in this trial stated that "Having a new therapeutic option for menopausal women which is effective in treating painful sex without the possible safety concerns of traditional hormonal treatments should provide more women the ability to stop dealing with the issue on their own and give them a reason to reach out to their OBGYN or Women’s Health Care Provider to get clinical support they need and discuss this novel solution."

In addition, in December of 2015, the U.S. Food and Drug Administration (FDA) accepted the filing of Endoceutics’ New Drug Application (NDA) for Intrarosa™, the current trade name for Prasterone 0.50% (6.5 mg) Vaginal Ovules. Endoceutics is seeking market approval for this product for postmenopausal women who suffer from moderate to serve dyspareunia, a major symptom of vulvovaginal atrophy.

"This NDA is an important event in the evolution of a new class of vaginal therapy that women and their health care provider can truly trust," says Dr. Fernand Labrie, Endocrinologist and Founder and CEO of Endoceutics Inc. "Endoceutics developed this novel vaginal therapy so that women have a prescription therapy that provides effective relief of painful sex without the concerns women have about traditional hormone treatments. The studies to support this product are a reflection of our longtime commitment to innovation in women's health.

About dyspareunia and vulvovaginal atrophy
The REVIVE survey was conducted from 31 May through 14 June 2012, among women in the United States who reported having vulvovaginal atrophy (VVA) and/or symptoms consistent with VVA. Postmenopausal women with VVA symptoms were identified through Knowledge Panel®, a 56,000-member panel demographically representative of the U.S. population developed and maintained by GfK Knowledge Networks. Of the 15,576 women in the Knowledge Panel who were contacted, a total of 10,486 women responded with 8081 (77%) self-identifying themselves as postmenopausal. A total of 3046 (38%) postmenopausal women reported they had experienced symptoms of VVA, with 44% of those women reporting that they had experienced dyspareunia/pain with sex and 55% reported vaginal dryness.

The REVIVE study demonstrates that many women experience the impact of dyspareunia on how women feel about sex and how they feel about themselves. According to the REVIVE study, the top three activities that were most impacted by VVA were

1. Enjoyment of sex (~63%),
2. Sexual spontaneity (~55%),
3. Ability to be intimate (~54%)

Although all participants who participated in the REVIVE survey had reported at least one symptom consistent with VVA, only 38% of women were aware of the VVA condition and only 24% and 12% attributed VVA symptoms to menopause or hormonal changes, respectively.

In the CLOSER study, the impact of painful intercourse was similar with the following results:

1. Having sex less often (58% women, 61% men),
2. Less satisfying sex (49% women, 28% men 28%),
3. Putting off having sex (35% women, 14% men)

About the Intrarosa™ Development Program
The NDA submission included data from five Phase III clinical trials and one Phase I/II. These trials enrolled a total of 1,552 women who received intravaginal prasterone and evaluated the efficacy of daily intravaginal administration of INTRAROSA™ on moderate to severe dyspareunia (or pain at sexual activity), a symptom of vulvovaginal atrophy due to menopause. Filing an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing does not indicate that approval has been or will be issued, nor does it represent an evaluation of the adequacy of the data submitted.

About Endoceutics
EndoCeutics is a private bio-pharma company operating in the field of women’s health and hormone-sensitive cancer prevention and treatment. EndoCeutics' research focuses on developing non estrogen-based therapies for vulvovaginal atrophy, sexual dysfunction and the other symptoms of menopause including hot flushes, osteoporosis, memory loss, cognition loss and possibly Alzheimer's disease. Hormonal therapies for prostate cancer, male hypogonadism as well as endometriosis are also under development.

EndoCeutics has three Phase III product candidates addressing large market opportunities and two Phase I/II product candidates. EndoCeutics has exclusive worldwide rights to patents, patent applications, technology and know-how related to all its products.
Jeff Solomon