DUBAI, UAE, May 20, 2018 /PRNewswire/ --
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.
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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."
For more information, please visit:
http://www.mundipharma.ae
References:
1 - Intrarosa US Prescribing Information
SOURCE Mundipharma