FDA Approves Drospirenone Tablet for Pregnancy Prevention

Officials with the FDA have approved Exeltis’ drospirenone 4 mg (Slynd) oral tablet for pregnancy prevention, according to the company.

A progestin-only pill, this estrogen-free oral contraceptive is intended as a 24 active and 4 inactive tablet dosing regimen. The regimen also allows a 24-hour missed tablet window.

According to Exeltis, a division of Insud Pharma, this contraceptive tablet could be made available by Fall 2019.

Drospirenone is a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone. In clinical trials, drospirenone showed no instances of thromboembolic events experienced by some women taking combined oral contraceptives (COCs), which by definition contain estrogen.

In addition, the approval of Exeltis’ New Drug Application for drospirenone does not include a black box warning, unlike other COCs, according to the company. However, for females with conditions that predispose to hyperkalemia, drospirenone 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, in a prepared statement.

According to Salustiano Perez, President of Exeltis USA, Inc. drospirenone may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen, including breastfeeding mothers.

Contraindications for drospirenone 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.

Reference

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 [news release]. Florham Park, NJ; June 6, 2019: Exeltis. https://www.prnewswire.com/news-releases/exeltis-usa-inc-announces-the-approval-of-slynd-the-first-and-only-progestin-only-pill-providing-pregnancy-prevention-with-a-244-dosing-regimen-and-24-hour-missed-pill-window-300863390.html. Accessed June 7, 2019.