FDA Approves Agile Therapeutics, Inc.’s Twirla (levonorgestrel and ethinyl estradiol) Transdermal System – A New Weekly Contraceptive Patch Delivering a 30 mcg Daily Dose of Estrogen and 120 mcg Daily Dose of Progestin
Twirla is a new non-daily, non-invasive contraceptive approved in the U.S.
PRINCETON, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Twirla (levonorgestrel and ethinyl estradiol) transdermal system.
INDICATION AND USAGE
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use
Consider TWIRLA’s reduced effectiveness in women with a BMI > 25 to < 30 kg/m2 before prescribing. TWIRLA is contraindicated in women with a BMI > 30 kg/m2.
Please see Important Safety Information for TWIRLA, including BOXED WARNING on Cigarette Smoking and Serious Cardiovascular Events and Contraindication in Women with a BMI > 30 kg/m2, below in “About Twirla.”
“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives,” said Dr. David Portman, a primary investigator on the SECURE clinical trial. “I’m pleased that Agile conducted a comprehensive study in a diverse population providing important data to prescribers and to women seeking contraception. It is vital to expand the full range of contraceptive methods and inform the choices that fit an individual’s family planning needs and lifestyle. I am excited healthcare providers can now include Twirla among available contraception options.”
Twirla is designed for weekly application to deliver a 30 mcg daily dose of ethinyl estradiol, a type of estrogen, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin with a long history in the category. The newly approved patch can be worn on the abdomen, buttock, or upper torso (excluding the breasts).
“The FDA’s approval of Twirla will enable us to deliver on our short-term goal of establishing Agile in the contraceptive prescription market and working towards our longer-term mission to broaden our women’s health portfolio, including in areas of unmet need. We are grateful to the clinical trial patients, researchers, healthcare providers, and advocates, whose contributions helped us secure the approval of a new transdermal contraceptive option that may serve the contraceptive needs and preferences of many women,” said Al Altomari, chairman and chief executive officer, Agile Therapeutics. "We are proud to offer this new option and look forward to bringing Twirla to women and their healthcare providers.”