PRINCETON, N.J.—Agile Therapeutics, Inc. has entered the U.S. market with their first approved product, Twirla: a levonorgestrel and ethinyl estradiol transdermal contraceptive patch. The Twirla patch is now available by prescription for those with a body mass index (BMI) < 30 kg/m2. The company notes that Twirla is less effective with a BMI ≥ 25 kg/m2, and should not be used with a BMI ≥ 30 kg/m2.
“We are thrilled to launch our first commercial product, Twirla, an effective, modern contraceptive option, for women and their healthcare providers,” said Al Altomari, chairman and chief executive officer of Agile Therapeutics. “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. Twirla is designed to be worn on the abdomen, buttock or upper torso (excluding the breasts). Twirla is less than 1mm thin, and is made up of five distinct layers for both focused drug delivery and to help maintain adhesion.
“Nearly all women use contraception at some point in their lives, but when it comes to preventing unplanned pregnancies, 90% of failures are attributed to inconsistent and/or improper use. Today, women need a birth control product that is not only safe and reliable, but also that fits seamlessly into an active lifestyle. The soft and flexible design of Twirla contours to a woman’s body, requires no invasive procedures, and reduces the burden of daily administration,” added Donnica Moore, M.D., president of the Sapphire Women’s Health Group and consultant for Agile Therapeutics. “I am excited that healthcare providers can now offer a new solution that can fill a gap in hormonal contraceptive care.”
Agile has also introduced The Loop, a website meant to provide additional personalized resources for those who use Twirla. Patients can access the Twirla patch replacement program and chat with qualified nurse-educators about patch use.
“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. 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,” concluded Paul Korner, M.D., MBA, chief medical officer of Agile Therapeutics.