SYDNEY--(BUSINESS WIRE)--Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, has expanded its original agreement with Endoceutics to commercialise Intrarosa® (prasterone) in Australia. Intrarosa is now available in this market as the first and only locally acting DHEA (dehydroepiandrosterone) treatment indicated for postmenopausal women experiencing moderate to severe symptoms associated with vulvovaginal atrophy (VVA).
Regeneron Pharmaceuticals Inc said on Thursday its experimental treatment for a very rare genetic bone disorder showed a nearly 90% reduction in new lesions compared to placebo, in a mid-stage study.
A unique non-estrogen prescription therapy, Intrarosa™, has been approved by the US Food and Drug Administration (FDA) and by the European Medical Agency (EMA), for the treatment of the most bothersome symptom of vulvovaginal atrophy, due to menopause, known as dyspareunia.
Endoceutics Intrarosa (Prasterone) Receives Approval in Europe
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting.
Endoceutics should have a U.S. distribution partner for Intrarosa, a newly FDA-approved treatment for vulvovaginal atrophy in postmenopausal women, before the end of the year, says founder and CEO Fernand Labrie.
This is the first product approved to treat sexual symptoms of menopause that contains the active ingredient, prasterone -- also known as dehydroepiandrosterone (DHEA), a dietary supplement that has been previously found to help treat sexual dysfunction associated with menopause.