The European Medicines Agency Accepts Marketing Authorisation Application for Intrarosa for the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

By , in PR PR Health on .
Quebec, Canada, November 13, 2017 — Endoceutics Inc., a private Quebec City based biopharma company, today announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product IntrarosaTM, intended for the treatment of vulvar and vaginal atrophy in postmenopausal women.

IntrarosaTM will be available as a 6.5 mg pessary. The active substance of IntrarosaTM is prasterone, also known as dehydroepiandrosterone (DHEA), a precursor steroid which is converted into oestrogens and androgens. The medicine increases the number of superficial and intermediate cells and decreases the number of parabasal cells in the vaginal mucosa via an oestrogen-mediated mechanism. In addition, it decreases the vaginal pH towards the normal range, thus facilitating the growth of the normal bacterial flora.

The benefit with IntrarosaTM is its ability to improve dyspareunia. The most common side effect is vaginal discharge.

The full indication is: “IntrarosaTM is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

About Endoceutics
Endoceutics is a private pharmaceutical company operating in the field of women’s health and hormone-sensitive cancer prevention and treatment. Following approval by the US FDA of Intrarosa™ in November 2016, for the treatment of dyspareunia, a symptom of vulvovaginal atrophy due to menopause, Endoceutics focuses on developing non estrogen-based therapies for sexual dysfunction and the other symptoms of menopause, including hot flushes, osteoporosis, muscle loss and type 2 diabetes. Hormonal therapies for breast, uterine and prostate cancer, male hypogonadism as well as endometriosis are also under development. Endoceutics has five 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.

The following two tabs change content below.
Brad Bennett

Brad Bennett

Brad grew up in a small town in northern Iowa. He studied chemistry in college, graduated, and married his wife one month later. They were then blessed with two baby boys within the first four years of marriage. Having babies gave their family a desire to return to the old paths – to nourish their family with traditional, homegrown foods; rid their home of toxic chemicals and petroleum products; and give their boys a chance to know a simple, sustainable way of life. They are currently building a homestead from scratch on two little acres in central Texas. There’s a lot to be done to become somewhat self-sufficient, but they are debt-free and get to spend their days living this simple, good life together with their five young children.
%d bloggers like this: