Swissmedic approves Intrarosa® (prasterone) for the treatment of vulvovaginal atrophy in postmenopausal women
A novel drug for the treatment of vulvovaginal atrophy based on prasterone (DHEA)
Geneva, the 02.06.2020 – On 19.05.2020, Swissmedic, the Swiss Agency for Therapeutic Products, granted a marketing authorization for the active substance prasterone for the local treatment of vulvovaginal atrophy in post-menopausal women. This medicine will be marketed as Intrarosa®, in the form of a vaginal insert containing 6.5 mg of prasterone. Prasterone is also known as dehydroepiandrosterone (DHEA).
The lack of sex hormones associated with menopause can cause thinning and dryness of the tissues of the vulva and vagina. DHEA is naturally secreted and is used to produce estrogen and androgen in the vagina. Intrarosa® can therefore compensate for insufficient natural sex hormones in women’s vagina after menopause. This medicine will physiologically improve the symptoms of vulvovaginal atrophy, including vaginal dryness, pain during sexual activity (dyspareunia), irritation and itching.
It is estimated that more than 50% of postmenopausal women suffer from vulvovaginal atrophy (1) (part of the genitourinary syndrome of menopause) but this topic remains taboo between women and their physicians (2). Yet evidence shows that vulvovaginal atrophy negatively affects women’s quality of life on a daily basis (1) .
Intrarosa® is a vaginal insert containing 6.5 mg of prasterone (DHEA), available in a pack of 28 inserts, with 6 reusable applicators. The recommended dose is a vaginal insert once a day at bedtime, with – or without – the use of the applicator provided (3) .
Prasterone is a naturally occurring steroid compound that is inactive by itself. After intravaginal administration, prasterone is converted to estrogen and androgen within the vaginal cells. Thus, Intrarosa® differs from estrogenic preparations as it also provides androgens that have a complementary effect on vaginal health. The sex hormones produced from prasterone inside the vaginal cells are then also inactivated locally in the same cells. That avoids the release of active sex steroids in the circulation (4) . Intrarosa® enables the application of this mechanism of action, also known as intracrinology (5) , in an innovative way for treating vulvovaginal atrophy in postmenopausal women.
Intrarosa® was developed in Quebec by Endoceutics, a company founded by the late Dr. Fernand Labrie (1937-2019). The product has been approved for sale in the United States, Europe and Canada since 2016, 2018 and 2019, respectively. Labatec is the selected partner to market Intrarosa in Switzerland. “Labatec is pleased to provide access in Switzerland to the first local DHEA-based treatment for vulvovaginal atrophy after menopause,” said Faisal Darwazeh, CEO at Labatec. “The inclusion of this innovative product in our portfolio illustrates Labatec’s strong commitment to improving women’s health.
The efficacy of Intrarosa® on dyspareunia and vaginal dryness, two symptoms of vulvovaginal atrophy due to menopause, as well as on three markers of vaginal health (vaginal pH and percentage of parabasal and superficial cells), has been demonstrated in several Phase III placebo-controlled clinical studies(6) .
The safety of Intrarosa® has been documented in several clinical studies, including a 52-week study (7) .
Private pharmaceutical company based in Meyrin (Geneva) since 1957, Labatec has more than 60 years of experience in the marketing of pharmaceutical products in Switzerland. Labatec develops and markets medicines that contribute to improving the quality of life of patients, in perfect synergy with the needs of the hospital and city sectors. Our portfolio includes more than 60 high quality products, mainly manufactured in Europe. Labatec is a recognized partner choice for Swiss hospitals (anti-infectious, anaesthetic, antiemetic and oncological products) and also has several ranges of prescription products in osteoporosis, muscle relaxants and women’s health. In particular, we offer a wide range of contraceptives at affordable prices for patients.
For more information, please visit http://www.labatecpharma.com/
Endoceutics, Inc. is based in Quebec City, Canada and is active in the field of women’s health and the prevention and treatment of hormone-sensitive cancers. Endoceutics specializes in all stages of research, clinical development, and drug production. Endoceutics benefits from a portfolio of products at different stages of development and has as mission to improve women’ life quality.
Contact for more information
Labatec Pharma SA, 1217 Meyrin (GE)
(1) Nappi, R. E., et al (2019). Addressing Vulvovaginal Atrophy (VVA)/Genitourinary Syndrome of Menopause (GSM) for Healthy Aging in Women. Frontiers in Endocrinology, 10, 561
(2) Parish, SJ., et al (2013). “Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy” Int J Womens Health, 5, 437–447.
(3) Professional information available on swissmedicinfo.ch, May 2020
(4) Labrie F. (2019). Intracrinology and menopause: the science describing the cell-specific intracellular formation of estrogens and androgens from DHEA and their strictly local action and inactivation in peripheral tissues. Menopause, 26(2), 220‐ doi:10.1097/GME.0000000000001177
(5) Labrie, F. et al (2017). Science of intracrinology in postmenopausal women. Menopause, 24(6), 702-712 doi: 10.1097/GME.0000000000000808
(6) Labrie, F. et al. (2016). Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause, 23. 10.1097/GME.0000000000000571.
(7) Ke Y et al. (2015). Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 24(3), 117-129