Exeltis USA, Inc. Announces the Launch of Slynd™(drospirenone) tablets, 4 mg, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24-hour missed pill window and 24/4 Dosing Regimen
FLORHAM PARK, N.J., Sept. 16, 2019 /PRNewswire/ — Exeltis USA, Inc. a division of Insud Pharma (headquartered in Madrid, Spain) today announced the commercial launch of its oral contraceptive tablet Slynd™ (drospirenone) tablets, 4 mg in the US market.
Slynd™, a progestin-only pill (POP), is a novel estrogen-free oral contraceptive product that provides a 24 active plus 4 inactive tablet dosing regimen and 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.
Slynd™ contains the active ingredient drospirenone—a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone. In clinical trials, Slynd™ showed no instances of thromboembolic events which some women taking combined oral contraceptives (COCs) with estrogen experience. In addition, the safety of Slynd™ is supported by its approval by the Food and Drug Administration (FDA) with no Boxed Warning unlike the COCs.
Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ 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.
“The Slynd™ safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and women with a Body Mass Index (BMI) >30,” observed Enrico Colli, MD, Chief Scientific Officer.
In addition, Salustiano Perez, President of Exeltis USA, Inc. noted that “Slynd™ is a POP that may fit the lifestyle of more patient types, especially breastfeeding mothers seeking a safe and effective oral contraceptive without the risks of estrogen and some of the dosing challenges.”
The launch of Slynd™ will be backed by a strong sales and marketing effort directed toward healthcare professionals in the field of Obstetrics and Gynecology, the medical specialty most involved in contraceptive patient consultation and prescribing.