Monday, May 21, 2018
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.
Mundipharma has been granted the commercial rights to Intrarosa™ (Prasterone) in the Middle East and Africa as part of an agreement signed between Mundipharma and Endoceutics, Inc.
Intrarosa™ (Prasterone) has been developed for the treatment of women experiencing moderate to severe dyspareunia, which is an outcome of vulvovaginal atrophy, that occurs due to menopause. Intrarosa™ is a unique non-estrogen product that is administered locally in order to exert an action limited to the vagina.[1]
Intrarosa™ was approved by the FDA in the US and by EMA for all countries of Europe. As the unique intracellular precursor of sex steroids in women, Intrarosa™ (Prasterone) is transformed into androgens and estrogens inside the vaginal cells without any biologically significant increase in estrogens or androgens found in the patient's blood. [1]
Ashraf Allam, Vice President of Mundipharma in the Middle East, Turkey and Africa Region, said: "Intrarosa™ is an unique new innovation that successfully tackles an important health issue for postmenopausal women who suffer from the painful condition of dyspareunia. We are looking forward to make this treatment available to women of our region. We are very excited to work with Professor Fernand Labrie, the founder and CEO of Endoceutics who has been at the forefront of this ground-breaking innovation".
"By adding Intrarosa™ to Mundipharma's growing portfolio and working closely with Dr Fernand Labrie, we will be able to rapidly introduce this new therapy to healthcare providers and their patients. It will allow Mundipharma to address unmet patient needs across the continuum of women's healthcare. It represents the continued development of its women's health division as part of the company's ongoing growth strategy" - he added.
"As a non-estrogen containing treatment, Intrarosa™ is a novel vaginal prescription therapy that locally replaces inside the cells what is missing for patients with vulvovaginal atrophy and moderate-to-severe dyspareunia, the most bothersome symptom of vulvovaginal atrophy or genitourinary syndrome of menopause " said Dr. Fernand Labrie, founder and Chief Executive Officer of Endoceutics. He also highlighted that "Intrarosa™ permits the body's natural ability to produce hormones intracellularly and locally, thus reducing pain at sexual activity without influencing the other tissues. Since Intrarosa™ is not an estrogen, patients may feel more comfortable seeking treatment.
Dr. Fernand Labrie also added "Unlike other medications that contain estrogens, Intrarosa™ was approved by the US FDA with no black box warning. Based upon highly supporting data, Intrarosa™ is currently being studied in clinical trials performed in the US and Canada for the treatment of sexual dysfunction, an unmet medical need."
