FDA approves first low-dose contraceptive patch Twirla after seven years of testing

Valentine’s Day marked a milestone in the history of women’s health, when the US  Food and Drug Administration (FDA) approved a new low-dose contraceptive transdermal patch, Twirla.

Twirla is devised by New Jersey-based women’s healthcare company, Agile Therapeutics, Inc. and provides a lower-dose contraception through patch technology. 

“Twirla stands out as the only low-dose transdermal contraceptive patch. Women are in need of more contraceptive options and Twirla will be only the second patch available to women, and it is a lower dose than the alternative,” said Toni Van Pelt, President of the National Organization for Women Foundation (NOW).

The approval of the non-daily prescription birth-control patch adds a safer and user-controlled option to the various contraceptives already available in the market. It is designed to be applied once every week for a period of 3 weeks, followed by a week of no application.

The low-dose contraception has active ingredients ethinyl estradiol, a synthetic estrogen and levonorgestrel, a type of progestin. The company said the patch induces a dose of 30mcg estrogen and 120mcg dose of progestin, daily.

The combined hormonal contraceptive can be availed by women who can become pregnant and have a body mass index (BMI) of less than 30kg/sq m. It is less effective for people with BMIs above the aforementioned. The patch can be worn on the abdomen, buttocks or even the upper torso, but not on the breasts, as specified by the company.

The approval process for Agile’s Twirla, though, was a whirlwind with exasperating setbacks. The New Drug Application (NDA) for the patch was rejected twice by the FDA in the past seven years — the first time in 2013 and the second time in 2017, despite the company submitting a more efficient NDA and safety data from a new PHASE III clinical trial.

Van Pelt opines that the reason for the delay could have been a clinical trial having to be repeated. The NOW Foundation presented a testimony before the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee in October 2019, asserting the need for more contraceptive choices for women as well as faster approval processes.
 
“It should be noted that emergency contraception was first used in the 1960s for survivors of rape, but it took almost four decades for the FDA in 1998 to approve the first product, an Emergency Contraception Kit,” she explained. “Then another 15 years before over-the-counter, no age restriction access was granted for Plan B One-Step OTC, after a court instructed the FDA to do so. That’s a total of more than half a century!”

Sarah Christopherson, Policy Advocacy Director at The National Women’s Health Network, alluded to past mistakes as another possible factor for the FDA’s initial rejection.

“In the early 2000s, Ortho Evra's maker Johnson & Johnson dangerously downplayed the true blood clot risks associated with their high-dose patch, leading to several dozen deaths and prompting a special warning from the FDA,” explained Christopherson, who also testified in support of Twirla before the FDA’s Advisory Committee.
 
The Twirla patch is supported by evidence from clinical data, in which over 2,000 women of reproductive age who tested the patch reported a 1.5-day reduction in unscheduled bleeding and spotting from the first to last cycle. The inferences also pointed out that scheduled periods of bleeding or spotting were reduced to an average of 3.7 days.
 
Talking about potential side-effects of the patch, Christopherson adds that just as in case of any other combined contraceptive, they could range from spotting and nausea to weight gain and a modestly increased risk of blood clots (though significantly lower than the blood clot risk associated with pregnancy).
 
While birth-control is approved to boost women's reproductive health, the most common misconception is that contraception is not healthcare. Besides preventing pregnancies, women go for birth control to help regulate their menstrual cycles, ovarian cysts, and other hormonal disorders.
 
“Birth control most definitely should be considered healthcare. It is preventive healthcare, as pregnancy and childbirth are more hazardous to a woman’s health than taking medication to prevent these conditions,” Van Pelt stresses.
 
She also suggests that the fact that contraception isn’t considered healthcare is partially due to the influence of extremist religious groups who oppose birth control.
 
Twirla’s manufacturer, Agile Therapeutics, Inc. has announced its plans to ship Initial batches of the contraceptive patch and make it commercially available in the last quarter of 2020.