Peer-Reviewed Publication Reinforces Safety and Efficacy of Slyndtm (Drospirenone) tablets, 4 mg

FLORHAM PARK, N.J., June 11, 2020 /PRNewswire/ -- Exeltis USA, Inc, a division of Insud Pharma, today released a physician and patient communication letter announcing a recent publication in Drugs of Today 2020 that highlights the Slynd safety data and the efficacy of drospirenone to inhibit ovulation, reinforcing the features and benefits of Slyndtm (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive.

The published article, "Drospirenone: a novel progesterone used as an oral contraceptive without an estrogen component" (D.M. Paton, 56(5): 321-328) reviews two phase III clinical studies of Slynd. The paper concludes that "it was a logical development to determine the efficacy of a tablet that only included [drospirenone] DRSP as an oral contraceptive" which gained approval by the Food & Drug Administration in May, 2019.

"There is an important place in the market for this next generation progestin-only pill for prevention of pregnancy," notes Randi Rievman, Senior Director, Marketing and Sales Training at Exeltis USA. "Slyndtm, which is proven safe and effective for contraception, is truly fitting a patient need in today's environment. Using telemedicine service providers, it can be prescribed without an office visit.  It doesn't require a blood pressure check before prescribing as the CDC guidance stipulates for other estrogen-containing oral contraceptives or need to be inserted like the IUDs." 

Exeltis, the license holder of Slyndtm, has taken additional measures during the current COVID-19 environment to make the progestin-only pill easily available to women in need of an oral contraceptive. The company has made sampling delivery safe and convenient for physicians and patients by enabling physicians to order samples sent directly to their offices or direct shipments to patient homes to further facilitate their ability to start their patients on Slyndtm.

"In the current COVID-19 environment, where there are many women physically distancing and unable to go to physician offices for visits, our program enables their doctors to help them access oral contraceptives without an office visit," said Rievman.

Slyndtm, a progestin-only pill (POP), is a novel estrogen-free oral contraceptive that has 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 a 24-hour window in the event of a delayed or missed dose, which is also very beneficial for breastfeeding mothers.

Slyndtm is indicated to prevent pregnancy among females of reproductive potential. Slyndtm is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slyndtm may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slyndtm if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slyndtm please see full Slyndtm Prescribing Information.

About Exeltis:
Exeltis is a fast-growing division of Madrid-based 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 Women's Health including contraception, pregnancy, birth, and menopause and has expanded its research in recent years to Central Nervous System (CNS), ophthalmology and endocrinology. In addition, to learn more, please visit us at exeltisusa.com.

For more information on Slyndtm and Important Risk Information, please visit slynd.com or contact Randi Rievman, Senior Director, Marketing and Sales Training | Exeltis USA | Phone: 973-803-5505.

SOURCE Exeltis USA, Inc