FDA approves Twirla contraceptive patch
The FDA recently approved Twirla, a weekly contraceptive patch containing 30 mcg ethinyl estradiol and 120 mcg levonorgestrel, for women of reproductive age with a BMI less than 30 kg/m2 and for whom a combined hormonal contraceptive is appropriate, its manufacturer announced in a press release.
Twirla (levonorgestrel and ethinyl estradiol, Agile Therapeutics) contains a boxed warning regarding the risk for CV events in women aged 35 years and older who smoke and have a BMI greater than 30 kg/m2. The patch can be worn on the abdomen, buttock, or upper torso, but not on the breasts, according to the company press release. Agile Therapeutics also stated that it plans to ship initial batches of the product to wholesalers in the fourth quarter of 2020.
Healio Primary Care previously reported that several phase 3 trials showed Twirla had a safety profile similar to other approved contraceptives. These trials also indicated that common adverse events tied to the patch’s use included nasopharyngitis, upper respiratory tract infection, nausea, headache and UTI. Severe adverse events occurred in less than 2% of patients and included cholelithiasis, deep vein thrombosis, pulmonary embolism and depression.
“Twirla is an important addition to available hormonal contraceptive methods, allowing prescribers to now offer appropriate U.S. women a weekly transdermal option that delivers estrogen levels in line with labeled doses of many commonly prescribed oral contraceptives,” David Portman, MD, a primary investigator on a Twirla clinical trial, said in the press release.
Agile Therapeutics stated that the FDA requires the company to perform a long-term prospective, observational post-marketing study comparing the risks for venous thromboembolism and arterial thromboembolism in new users of Twirla to new users of other combined hormonal contraceptives. Interim safety data from that study is due in November 2026 and full study results are due in November 2032. The company also agreed to a post-marketing commitment study to assess the patch’s residual drug content and strength of Twirla in a minimum of 25 women.
The company indicated that more products are forthcoming.
“The FDA’s approval of Twirla will enable us to ... work towards our longer-term mission to broaden our women’s health portfolio, including in areas of unmet need,” Al Altomari, Agile Therapeutics’ chairman and CEO, said in the press release.
Disclosures: Altomari is Agile Therapeutics’ chairman and CEO. Healio Primary Care could not confirm Portman’s relevant financial disclosures at the time of publication.
Editor’s note: This story has been updated with the correct dosages of the two drugs used in Twirla. The editor regrets the error.