Annovera (US) · Contraception
Development and Regulatory status
Aug 18: FDA advise that women aged >35 who smoke should not use Annovera, and the ring carries a boxed warning relating to cigarette smoking and serious cardiovascular events, similar to other hormonal contraceptives. The FDA is requiring postmarket studies on the risk of venous thromboembolism and the effects of tampon use and CYP3A modulating drugs on Annovera’s pharmacokinetics.
Aug 18: Approved by FDA. It is expected that Annovera will be fully commercially available in late 2019 or early 2020.
Jan 18: Filed for approval with US FDA.·
Trial or other data
Jan 18: Two pivotal PIII trials (NCT00455156 and NCT00263341) involving 2270 healthy women aged 18 to 40 years evaluated its safety and efficacy. These showed that ~2-4 women out of 100 may get pregnant during the first year they use Annovera as directed.[2,3]
A self-administered silicone rubber vaginal ring composed of ethinyl estradiol + segestrerone acetate (a 4th generation progestin) has been developed by the Population Council (USA) who is developing it with TherapeuticsMD in the USA. The ring is designed to last for 1 year before being replaced, allowing long term delivery of the drugs. It is washed and stored in a compact case for the seven days it´s not in use during a four-week menstrual cycle. It does not require refrigeration and can withstand storage up to 86°F (30°C).[2,3]·