Twirla® Contraceptive Patch
Levonorgestrel + Ethinyl Estradiol Patch, AG200-15
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Transdermal
-
Intended Duration:
- Short-Acting
- Development Stage: Single-Country Approval
- Developer(s)/researcher(s): Agile Therapeutics, Exeltis USA
Details
- API: Levonorgestrel, Ethinyl Estradiol
- Target: Estrogen Receptor, Progesterone Receptor
-
Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Regimen: 1 Patch/Week
- MPT: Not Potential MPT
- Promising Attributes: A combined hormonal method has the potential to offer regular bleeding patterns with high contraceptive efficacy. The patch requires less user adherence than a daily-use method.
Product Status
Single-Country Approval: United States, Active/Recent Post-Marketing Research
History
2008: Phase II Study of LNG-EE Patch - Ovulation & Cycle Control Trial
2009: Phase I Study of LNG-EE Patch - Comparative Trial
2011: Phase I Study of LNG-EE Patch - Environmental Considerations
2011: Phase I Study of LNG-EE Patch - PK Study
2011: Phase III Study of LNG-EE Patch - Efficacy and Safety
2012: Phase I/II Study of LNG-EE Patch - PK, Wearability & Safety
2016: Phase III Trial of LNG-EE Patch - Efficacy, Safety, and Tolerability
2020: FDA Approval for Twirla, LNG-EE Patch, with requirement for post-approval studies
2023: Agile announces modified post-approval research plan, allowing for health systems data to stand in for clinical results in their mandated evaluation of thromboembolism risk for Twirla users in comparison to new users of combined pills and new users of Ortho Evra patches. This post-marketing requirement study will share interim results in 2029 and final results in 2035.
2024: Agile is acquired by Insud Pharma and merged into their existing US-based subsidiary Exeltis USA. Twirla remains marketed by Exeltis.