Introduction
Agile Therapeutics (NASDAQ: AGRX) is a women’s healthcare company focused on patch-based contraceptive options. Their lead product, Twirla, is a once-a-week contraceptive patch containing a combined dose of levonorgestrel and ethinyl estradiol. Twirla was recently approved by the FDA on February 14, 2020 for women with a BMI < 30 kg/m2 and is contraindicated in women with a BMI > 30 kg/m2.
Twirla endured a long and difficult path to approval, including several CRLs and a scathing set of briefing documents issued by the FDA prior to their AdComm in