Exeltis Announces Positive Conclusion for the European Decentralised Procedure for a New Oestrogen-free Oral Contraceptive: Drospirenone Only Pill, 4mg
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 of
oestrogen and offers an improved bleeding profile, making it suitable for the majority of women
* DOP has demonstrated an efficacy comparable to combined oral contraception
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 bleeding days.
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 Officer.
About Exeltis:
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 Endocrinology.
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