Exeltis USA get FDA nod for Slynd birth control
Exeltis USA, a division of Insud Pharma, has received the green light from the Food and Drug Administration for Slynd, an oral contraceptive tablet for pregnancy prevention containing 4 mg of drospirenone.
Slynd, a progestin-only pill 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, the company said.
"This safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and subjects with a Body Mass Index less than 30," Enrico Colli, chief scientific officer said.
"Slynd may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen. Slynd may be an ideal choice for a breastfeeding mother," Salustiano Perez, Exeltis USA president said.
The commercial launch of Slynd is anticipated in early fall 2019.
Slynd, a progestin-only pill 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, the company said.
"This safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and subjects with a Body Mass Index less than 30," Enrico Colli, chief scientific officer said.
"Slynd may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen. Slynd may be an ideal choice for a breastfeeding mother," Salustiano Perez, Exeltis USA president said.
The commercial launch of Slynd is anticipated in early fall 2019.