Progestin-Only Contraceptive Slynd Gets FDA Approval

The Food and Drug Administration (FDA) has approved Slynd (drospirenone; Exeltis) for use by females of reproductive potential to prevent pregnancy.

Slynd, a progestin-only oral contraceptive, lowers the risk of becoming pregnant primarily by suppressing ovulation. It contains the synthetic progestin drospirenone in a 4mg dosage strength that is given in a 24/4 dose regimen. Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity.

The efficacy of Slynd in preventing pregnancy was evaluated in a single arm trial involving 953 female patients ≤35 years of age with 5547 evaluable cycles. Study findings showed that during these cycles, 1.8% of patients (n=17) reported pregnancy, resulting in a Pearl Index of 4.0 (95% CI: 2.3-6.4).

With regard to bleeding patterns, the percentage of females experiencing scheduled bleeding or unscheduled bleeding/spotting decreased over time. Based on subject diaries from 4 clinical trials, 64.4% of females experienced unscheduled bleeding at Cycle 1 which decreased to 40.3% by Cycle 13.

Slynd is supplied in blister cards, each holding 24 white tablets containing drospirenone 4mg and 4 green inert tablets.

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