Exeltis USA, Inc. Announces the Approval of Slynd, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window
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Press Release[/caption]
FLORHAM PARK, N.J., June 6, 2019 /PRNewswire/ -- Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd? (pronounced "slind") containing drospirenone 4 mg, an oral contraceptive tablet for pregnancy prevention.
Slynd?, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive that is intended as a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.? This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to 24 hours in the event of a delayed or missed dose.
In clinical trials, Slynd? (a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone) showed no instances of thromboembolic events experienced by some women taking COCs, which by definition contain estrogen.? In addition, the safety of Slynd? is supported by its approval with no black box warning unlike other combined oral contraceptives.? But for females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment and adrenal insufficiency), Slynd? is contraindicated due to its anti-mineralocorticoid activity.
"This safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and subjects with a Body Mass Index (BMI) >30," said Enrico Colli, MD, Chief Scientific Officer.
Salustiano Perez, President of Exeltis USA, Inc. observed "Slynd? may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen. Slynd may be an ideal choice for a breastfeeding mother."
Slynd? is indicated to prevent pregnancy among females of reproductive potential. Contraindications include renal impairment, adrenal insufficiency, presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or hepatic impairment, or undiagnosed abnormal uterine bleeding.
The commercial launch of Slynd??is anticipated in early Fall 2019.
About Exeltis:
Exeltis is a 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 discover, develop, produce and seek new medicines and medical 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 fields of fertility, reproductive health, contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to CNS, ophthalmology and endocrinology. In addition, to learn more, please visit us on www.Exeltisusa.com and follow us on Twitter or Facebook. For further information:?contact Randi Rievman, Senior Director, Marketing|Exeltis USA|Phone: 973-324-0200 ext.3020 SOURCE Exeltis
Press Release[/caption]
FLORHAM PARK, N.J., June 6, 2019 /PRNewswire/ -- Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd? (pronounced "slind") containing drospirenone 4 mg, an oral contraceptive tablet for pregnancy prevention.
Slynd?, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive that is intended as a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.? This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to 24 hours in the event of a delayed or missed dose.
In clinical trials, Slynd? (a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone) showed no instances of thromboembolic events experienced by some women taking COCs, which by definition contain estrogen.? In addition, the safety of Slynd? is supported by its approval with no black box warning unlike other combined oral contraceptives.? But for females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment and adrenal insufficiency), Slynd? is contraindicated due to its anti-mineralocorticoid activity.
"This safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and subjects with a Body Mass Index (BMI) >30," said Enrico Colli, MD, Chief Scientific Officer.
Salustiano Perez, President of Exeltis USA, Inc. observed "Slynd? may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen. Slynd may be an ideal choice for a breastfeeding mother."
Slynd? is indicated to prevent pregnancy among females of reproductive potential. Contraindications include renal impairment, adrenal insufficiency, presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or hepatic impairment, or undiagnosed abnormal uterine bleeding.
The commercial launch of Slynd??is anticipated in early Fall 2019.
About Exeltis: Exeltis is a 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 discover, develop, produce and seek new medicines and medical 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 fields of fertility, reproductive health, contraception, pregnancy, birth, and menopause and has expanded its reach in recent years to CNS, ophthalmology and endocrinology. In addition, to learn more, please visit us on www.Exeltisusa.com and follow us on Twitter or Facebook. For further information:?contact Randi Rievman, Senior Director, Marketing|Exeltis USA|Phone: 973-324-0200 ext.3020 SOURCE Exeltis
