Twirla is a weekly patch that contains levonorgestrel (120 g/day) and ethinyl estradiol (30 g/day) is manufactured by Agile Therapeutics. It was previously approved for women with a BMI less than 30 kg/m2. However, in a study, researchers have found that Twirla was well-tolerated among women with a BMI of 25 to 30 kg/m2 as well as those with a BMI less than 25 kg/m2. The study findings were published in the journal Contraception on November 28, 2020. Recently the study findings were presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting.
"There wasn't a contraceptive out there that fit these criteria that many women were looking for, so I was excited to get involved in the Twirla study," told Dr Anita L. Nelson, MD, Lead Author and Primary Investigator in the SECURE study in an interview. "I believe that women should be able to choose the birth control option that works best for them, and it is our job as clinicians to find and test more options that will better suit their needs."
The previous approval of Twirla was based on Phase 3 SECURE trial, a United States, multicenter, single-arm, open-label, 13-cycle trial that evaluated the efficacy, safety and tolerability of Twirla in 2,032 healthy women. Dr Anita and her team conducted a post hoc analysis of Secure trail to assess the efficacy, safety and tolerability of Twirla in women with BMI < 25 kg/m2 and BMI 25-30 kg/m2.
The researchers reported that the patch was 97% effective and associated with a Pearl Index of 3.46 among participants in the lower BMI group. Meanwhile, it was 94.6% effective and associated with a Pearl Index of 5.69 among those in the higher BMI group.
"The results of this post hoc analysis help to inform providers counseling women that fall within BMI 25-30 kg/m2 who may be considering a non-oral, noninvasive contraception option," said Anita Nelson, MD, "These data support the safety and tolerability of Twirla in women within BMI 25-30 kg/m2 as well as those with BMI < 25 kg/m2."
Dr Paul Korner, MD, MBA, Chief Medical Officer for Agile Therapeutics said, "This post hoc analysis provides additional information about Twirla relative to the BMI categories for which Twirla is indicated that could facilitate data-driven conversations between healthcare providers and their patients."
For further information:
DOI:Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results
Anita L Nelson
Agile Therapeuitcs Press release