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August 13, 2018

Annovera contraceptive device gets US regulatory nod

Non-profit research organisation Population Council has secured the US Food and Drug Administration (FDA) approval for a new contraceptive vaginal ring called Annovera.

Non-profit research organisation Population Council has secured the US Food and Drug Administration (FDA) approval for a new contraceptive vaginal ring called Annovera.

Annovera is a segesterone acetate and ethinyl estradiol vaginal system and the first device of its kind approved for one-year usage. The non-biodegradable, flexible silicone ring is intended to prevent unintended pregnancy.

The device does not require refrigeration, which is considered beneficial for distribution as well as use in a low-resource environment.

“Annovera is expected to be commercially available from the third quarter of next year, with commercial launch scheduled for the fourth quarter of next year or the first quarter of 2020.”

Population Council president Julia Bunting said: “Nearly half of all pregnancies in the US are unintended, which can increase health risks for mom and baby.

“Having a single contraceptive system that provides a full year of protection while under a woman’s control could be a game-changer for some women.”

The FDA decision is partially based on results from 17 clinical trials, including two pivotal Phase III safety and efficacy studies.

During the Phase III programme, nearly 2,308 women were enrolled at 27 clinical sites across the US, Latin America, Europe and Australia.

Data revealed 97.3% effectiveness of Annovera in preventing pregnancy when used as directed.

However, the device comes with a risk profile similar to other combined hormonal contraceptives, along with a boxed warning for increased cardiovascular risk when used while smoking.

The Population Council signed the licence agreement with healthcare firm TherapeuticsMD for the commercial launch of Annovera in the US.

Under the arrangement, TherapeuticsMD will offer the device at a significantly lower price to certain clinics that serve lower-income women.

Annovera is expected to be commercially available from the third quarter of next year, with commercial launch scheduled for the fourth quarter of next year or the first quarter of 2020.

The Population Council is working for global availability of Annovera, including in low and middle-income countries.

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