FDA approves Slynd for contraception

Exeltis USA announced that the FDA has approved the new drug application (NDA) for Slynd (drospirenone 4 mg), an oral contraceptive tablet for pregnancy prevention. Slynd, a progestin-only pill (POP) is 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.

In clinical trials, Slynd (a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone) showed no instances of thromboembolic events experienced by some women taking COCs, which by definition contain estrogen. In addition, the safety of Slynd is supported by its approval with no black box warning unlike other combined oral contraceptives. But for females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment and adrenal insufficiency), Slynd is contraindicated due to its anti-mineralocorticoid activity.