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Biopharmaceuticals FDA

 News Release - November 29, 2018

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis

This new method of contraception could offer an improved bleeding profile and greater flexibility for female population

SlindaŽ has demonstrated that in case of missing a pill, there is no impact in the efficacy during the following 24 hours


FLORHAM PARK, New Jersey, November 29, 2018 -- (Healthcare Sales & Marketing Network) -- The pharmaceutical multinational Exeltis, with a strong position in Women's Health, has received acceptance from the US Food and Drug Administration (FDA) of the filing of SlindaŽ (4mg Drospirenone-only pill), the novel oral contraceptive developed by the company. The Prescription Drug User Fee Act (PDUFA) date is expected during the 27 May of 2019.

SlindaŽ is an investigational estrogen-free oral contraceptive, with a 24/4 dose regimen that is believed to have a favourable safety and efficacy profile.

"Developed by Exeltis, part of the global pharmaceutical group Insud Pharma, SlindaŽ showed to be safe, efficacious and well tolerated during extensive clinical trials. Once available in the market, it could give an improved bleeding profile and greater flexibility, maintaining contraception efficacy for up to 24 hours in the event of a delayed or missed pill dosage," said Yann Brun, Managing Director Exeltis.

Drospirenone is a synthetic progestin with a pharmacological profile similar to natural-produced progesterone. As an estrogen-free contraceptive option, SlindaŽ is expected to reduce the cardiovascular risks associated with Combined Hormonal Contraceptives (CHCs) and to offer all the unique advantages of drospirenone in terms of safety and tolerability and antimineralocorticoid and antiandrogenic activity.

"We are delighted that SlindaŽ brings us one step closer to providing women in the United States with a new effective, safe and well-tolerated method of contraception," commented Salustiano Perez, President Exeltis USA.

The submission of SlindaŽ is based on an extensive development programme involving more than 3,000 patients, generating over 20,000 cycles. The study showed that Drospirenone 4 mg-only pill has a clinical efficacy historically comparable to CHCs. "No cases of thromboembolic events were reported in the entire clinical programme. The safety profile was demonstrated for all women, even higher-risk population segments, such as smokers, over-35s and obese patients," said Enrico Colli, MD, Chief Scientific Officer.

Bleeding profile and novel dosing regimen

According to the results shown in the clinical study, Drospirenone 4mg-only pill may offer a more favourable bleeding profile than other estrogen-free contraceptives.

SlindaŽ is intended to give greater flexibility than other estrogen-free contraceptives, having demonstrated that in case of missing a pill, there is no impact in the efficacy during the following 24 hours, while with other estrogen-free options this is reduced to 12 hours.

About Exeltis

Exeltis is fast growing division of Insud Pharma, an integrated health sciences group. It has developed a leading position in the Women's Health sector, where it continues to innovate and seek new medicines and devices to improve the health and wellbeing of Women around the world. With a geographical footprint spanning over 40 countries, Exeltis employs over 4,000 professionals supported by a global production network. Exeltis strives to provide care for women throughout their lives. Exeltis offers a broad portfolio of products to respond to patients' needs in the field of fertility, reproductive health, contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to CNS, Ophthalmology and Endocrinology.


Source: Exeltis

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