Two New Publications Support the Safety and Efficacy of Slynd™ (drospirenone) tablets, 4 mg
FLORHAM PARK, N.J. July 7, 2020 – Exeltis USA, Inc., a division of Insud Pharma, today communicated that 2 new articles published in Contraception and The European Journal of Contraception & Reproductive Health Care, reviewed the US Phase III clinical study involving Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive in a physician and patient communication letter.
The publications highlighted the safety and efficacy of drospirenone 4 mg, similarly to the FDA which approved the Slynd™ NDA in May 2019.The first in Contraception, “A one-year prospective, open-label, single arm, multicenter phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only drospirenone 4 mg using a 24/4 daily regimen” (Kimble et al; February 21, 2020), indicated that drospirenone provides a contraceptive option for the majority of women regardless of blood pressure and BMI. The second, “Estrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and review of the literature” (Palacios et al; April 21, 2020), published in The European Journal of Contraception & Reproductive Healthcare-, concluded that drospirenone 4mg has shown contraceptive effectiveness similar to that of currently available COCs (combined oral contraceptives), very low cardiovascular side effects and a favorable bleeding pattern.
“We are pleased to see the Slynd™ clinical study results being reported in renowned journals,” said Randi Rievman, Senior Director, Marketing and Sales Training for Exeltis. “The data validates what we have known for some time: Slynd™ is an attractive option for many women who want or need an estrogen-free oral contraceptive. It offers the right balance of safety and efficacy to address the needs of many women, especially for those who may not be good candidates for other currently available oral contraceptive options.”
In addition to these findings, Exeltis USA President Salustiano Perez added, “Slynd™ is further differentiated in the market because it is an estrogen-free oral contraceptive product that provides a 24 active plus 4 inactive tablet dosing regimen and allows a 24-hour missed pill window.”
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. Slynd™ 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 Slynd™ if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd™ please see full Slynd™ Prescribing Information.