Madrid (ots/PRNewswire) - The pharmaceutical multinational Exeltis, a
division of the global pharmaceutical group Insud Pharma, today
announced that the European Decentralized Procedure (with Sweden as
RMS) for its 4mg drospirenone-only pill - the novel oral
contraceptive developed by the company - has concluded with a
favourable outcome. This is the first research novel product
developed by Exeltis, which boasts a strong position in Women's
Health, and marketing authorizations are expected to be issued in the
coming months by the competent national authorities in every relevant
EU Member State. This DCP approval comes five months after
Drospirenone 4mg secured FDA approval under the name Slynd(TM).
* Drospirenone Only Pill (DOP) is the first research novel product
approved by the European Health Authorities for Exeltis and the
entire Insud Pharma group
* DOP is safer than combined contraceptives thanks to the absence
oestrogen and offers an improved bleeding profile, making it
suitable for the majority of women
* DOP has demonstrated an efficacy comparable to combined oral
Drospirenone 4mg is a unique Drospirenone Only Pill (DOP). It is
oestrogen-free and offers a 24+4 intake scheme, which induces
scheduled bleeding and reduces unscheduled bleeding. DOP has a more
favourable bleeding profile than desogestrel 75 mcg, with fewer
The efficacy of DOP is comparable to other oral contraceptives, with
a PI of 0.73, and it is safe with regard to cardiovascular effects.
No thromboembolic events were reported in the development program.
Drospirenone is a synthetic progestin with a pharmacological profile
similar to natural-produced progesterone. As an oestrogen-free
contraceptive option, DOP reduces the cardiovascular risks associated
with Combined Hormonal Contraceptives (CHCs) and offers all the
unique advantages of drospirenone in terms of tolerability, thanks to
its antimineralocorticoid and antiandrogenic activities.
"We are delighted that DOP will provide women with an effective,
safe, well-tolerated method of contraception; a new alternative for
women who need or want an oral contraceptive without the risks of
oestrogen," said Yann Brun, Managing Director of Exeltis.
"We ran a highly extensive clinical program including 20 studies
involving more than 2,000 women, leading to around 22,000 exposure
cycles in Europe and in the US. We included high-risk population,
unlike other hormonal contraceptive programs, with no reports of
thromboembolic events," observed Enrico Colli, MD, Chief Scientific
Exeltis is a fast-growing division of the integrated health sciences
group Insud Pharma. It boasts a leadership position in the Women's
Health segment, and is constantly innovating and seeking new
treatments and devices to improve women's health and wellbeing around
the world. With a global footprint spanning over 40 countries,
Exeltis has a team of more than 4,000 professionals supported by a
global manufacturing network. Exeltis' overarching goal is to support
and care for women throughout every stage of life. It offers an
extensive portfolio of products to respond to women's needs in the
areas of fertility, reproductive health, contraception, pregnancy,
childbirth and menopause. In recent years, Exeltis has also
diversified into Central Nervous System (CNS), Ophthalmology and
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