FDA Approves New Contraceptive Patch

The Food and Drug Administration (FDA) has approved Twirla (levonorgestrel and ethinyl estradiol) transdermal system (Agile Therapeutics) as a method of contraception for use in women of reproductive potential with a body mass index (BMI) <30kg/m² for whom a combined hormonal contraceptive is appropriate.

The transdermal system is designed to deliver 120mcg of levonorgestrel and 30mcg of ethinyl estradiol per day and is applied once every 7 days for 3 consecutive weeks followed by 1 week without a patch, when withdrawal bleeding is expected. The patch can be applied to the abdomen, buttock or upper torso (excluding breasts).

Twirla is contraindicated in women with a BMI ≥30kg/m², while the effectiveness of the product may be reduced in women with a BMI ≥25 to <30kg/m². A summary of efficacy results from an open-label, single-arm trial (N=2031) showed that the overall Pearl Index (PI) in the primary efficacy population (18-35 years old [n=1736]; mean BMI: 28.3kg/m²) was 5.8 (95% CI, 4.5-7.2). Study findings also demonstrated a difference in efficacy based on BMI subgroup analysis: 

• BMI <25kg/m²: PI was 3.5 (95% CI, 1.8-5.2) based on 6007 evaluable cycles
• BMI  ≥25 and <30kg/m²: PI was 5.7 (95% CI, 3.0-8.4) based on 3881 evaluable cycles
• BMI ≥30kg/m²: PI was 8.6 (95% CI, 5.8-11.5) based on 5264 evaluable cycles.

With regard to safety, the most common adverse reactions in Twirla users were application site disorders, nausea, headache, dysmenorrhea, and increased weight. As part of the FDA approval, Agile will need to conduct a long-term perspective, observational postmarketing study to compare the risk for venous thromboembolism and arterial thromboembolism in Twirla users compared with users of other combined hormonal contraceptives. 

Twirla will be supplied in a carton containing 3 transdermal systems and is expected to be available in the fourth quarter of 2020. Currently, the only other combined hormonal contraceptive transdermal system available on the market is a generic version of Ortho Evra (Xulane), which delivers 150mcg of a different progestin, norelgestromin, and 35mcg of ethinyl estradiol per day.

For more information visit agiletherapeutics.com.