FDA Approves Oral Contraceptive Slynd

The US Food and Drug Administration (FDA) has approved Slynd (drospirenone) for use as an oral contraceptive pill. The pill contains drospirenone 4 mg and comes in sets of 24 active pills along with 4 inactive tablets.

The New Drug Application (NDA) for drospirenone was submitted to the FDA by Exeltis USA, Inc, which announced the approval of this progestin-only contraceptive tablet.

"Slynd may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen,” said Salustiano Perez, President of Exeltis USA, Inc. “Slynd may be an ideal choice for a breastfeeding mother."

Drospirenone allows for 24-hour missed or delayed pill window while maintaining safety and efficacy in preventing pregnancy.

In clinical trials, drospirenone did not produce thromboembolic events that sometimes occur with the use of combined oral contraceptive pills, which contain estrogen. The most common adverse reactions (>1%) were acne, metrorrhagia, headache, breast pain, increased weight, dysmenorrhea, nausea, vaginal hemorrhage, decreased libido, breast tenderness, and irregular menstruation.

"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 at Exeltis USA.

The contraceptive pill is contraindicated for people with renal impairment, adrenal insufficiency, presence or history of progestin sensitive cancers, benign or malignant liver tumors, hepatic impairment, or undiagnosed abnormal uterine bleeding.

Drospirenone was first approved by the FDA in 2001 and has been used in combination with other drugs to prevent pregnancy as well as to treat symptoms associated with menopause.

The company intends to commercially launch Slynd in the early fall of 2019.