FDA Approves sNDA for Annovera, a Procedure-Free, Long-Lasting, Reversible Birth Control

Officials with the FDA have approved a supplemental new drug application for the segesterone acetate and ethinyl estradiol vaginal system (Annovera, TherapeuticsMD) the only FDA-approved procedure-free, long-lasting, reversible birth control. The new approval includes minor revisions to the segesterone acetate and ethinyl estradiol vaginal system’s in vitro release testing specification that enabled normal manufacturing variability.¹

Originally approved in 2018, the segesterone acetate and ethinyl estradiol vaginal system is a vaginal ring contraceptive that can be used for an entire year. It is a non-biodegradable, flexible vaginal system that is placed in the vagina for 3 weeks followed by one week out of the vagina, at which time patients may experience a period. This schedule is repeated every 4 weeks for one year.²

The ring is washed and stored in a compact case for the 7 days not in use. It does not require refrigeration prior to dispensing and can withstand storage temperatures up to 86 degrees.²

With the new approval, manufacturers believe 7000 new rings will be able to enter the supply chain and will be available to customers in the second and third quarters of 2022. According to a press release, the approval will allow TherapeuticsMD to meet short- and long-term customer demand.¹

“Today’s approval is an important milestone as it will allow us to more efficiently scale, manufacture, and consistently supply Annovera to meet the increasing demand by women who want procedure-free, long-lasting reversible birth control,” said Hugh O’Dowd, CEO of TherapeuticsMD, in the press release.¹

The segesterone acetate and ethinyl estradiol vaginal system does carry a boxed warning related to cigarette smoking and serious cardiovascular events. Women over 35 years of age who smoke should not use the segesterone acetate and ethinyl estradiol vaginal system as cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use. It is contraindicated in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe cirrhosis; undiagnosed abnormal uterine bleeding; and in women using a hepatitis C drug combination containing ombitasvir, paritaprevir, or ritonavir.²

The most common adverse events are similar to those experienced with other combined hormonal contraceptive products, including headache or migraine, nausea or vomiting, yeast infections, abdominal pain, dysmenorrhea, breast tenderness, irregular bleeding, and diarrhea.²

REFERENCES

1. TherapeuticsMD Receives US Food and Drug Administration Approval for Supplemental New Drug Application (sNDA) for Annovera. News release. May 20, 2022. Accessed May 23, 2022. https://www.businesswire.com/news/home/20220520005266/en
2. FDA approves new vaginal ring for one year of birth control. News release. FDA; August 10, 2018. Accessed May 23, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-new-vaginal-ring-one-year-birth-control