FDA nod for Slynd, first progestin-only oral contraceptive

The US Food and Drug Administration has approved the new drug application (NDA) for Slynd containing drospirenone 4mg, an oral contraceptive tablet for pregnancy prevention.

Developed by Exeltis USA, part of the Insud Pharma group, Slynd is a progestin-only pill (POP) and a novel estrogen-free oral contraceptive that is intended as 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 24 hours in the event of a delayed or missed dose.

"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 Dr Enrico Colli, chief scientific officer.