Agile Therapeutics launches Twirla contraceptive patch
Agile Therapeutics is introducing Twirla (levonorgestrel and ethinyl estradiol) transdermal system, a nondaily, non-invasive contraceptive patch.
Twirla is indicated for women of reproductive potential with a body mass index less than 30 for whom a combined hormonal contraceptive is appropriate to prevent pregnancy. The company said that Twirla is less effective in women with a BMI between 25 and 30, and should not be used in women with a BMI of 30 or more.
“We are thrilled to launch our first commercial product, Twirla, an effective, modern contraceptive option, for women and their healthcare providers,” said Al Altomari, Agile chairman and CEO. “Family planning experts believe the most successful contraception for a woman is one of her choosing that fits her lifestyle, and we believe Twirla will be a valuable addition to the category’s available options. We are committed to seeking ways to make Twirla affordable and accessible for women.”
Twirla is worn weekly and delivers a 30-mcg daily dose of ethinyl estradiol, the lowest exposure of estrogen in a transdermal contraceptive option, along with a 120-mcg daily dose of levonorgestrel, a well-known progestin with a long history of use in the category.
Twirla is designed to be worn on the abdomen, buttock, or upper torso (excluding the breasts), using Skinfusion technology. At less than 1mm thin, Twirla is made up of five layers for focused drug delivery and to help maintain adhesion.
“The approach that we have taken in the development and launch of Twirla is representative of Agile’s ongoing dedication to addressing the unmet needs of today’s women,” said Paul Korner, chief medical officer of Agile. “Not only did we design our Phase 3 trial to closely represent the U.S. demographics of women, but we also worked with women over the last four years to better understand their evolving needs to ensure our patient programs holistically support women who use Twirla.”