First oral combined estetrol contraceptive available in UK
Posted: 20 October 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The first oral contraceptive tablet using a combination of estetrol (E4) and drospirenone (DRSP) is available in the UK.
Gedeon Richter has announced that its combined oral contraceptive Drovelis® is the first tablet containing estetrol (E4) and drospirenone (DRSP) to be made available on the NHS in England.
The drug (14.2mg estetrol and 3mg drospirenone) is the first oral combined contraceptive containing a new, synthetic natural oestrogen to be offered to patients in the UK.
“For the first time, we are now able to prescribe a combined hormonal contraceptive tablet containing synthetic E4, plus the well-known progestogen DRSP,” explained Dr Diana Mansour, Consultant in Community Gynaecology and Reproductive Health Care, Newcastle upon Tyne.
The Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for the product in 2021.
This Marketing Authorisation was based on two successful Phase III randomised control trials. The first: E4 FREEDOM trial, conducted in Europe and Russia, enrolled 1,553 women aged between 18 and 50 years. The second: Study MIT-Es0001-C302 enrolled 1,864 women between 16 and 50 years in the US and Canada.
The primary endpoint for both trials was 13-cycle Pearl Index (PI) (number of pregnancies per 100 woman-years of exposure) for women aged 18 to 35 years and 16 to 35 years, respectively.
The PI from E4 FREEDOM for E4/DRSP in at-risk cycles was 0.47 (95 percent Confidence Interval (CI): 0.15-1.11). The PI from Study MIT-Es0001-C302 reported more pregnancies compared to E4 FREEDOM, with an at-risk cycle PI of 2.65 (95 percent CI: 1.73, 3.88).
The secondary endpoint for both trials was to evaluate the contraceptive efficacy, bleeding patterns and overall safety of the drug in women of the reproductive years 18-50 and 16-50.
The current known safety profile for the new drug combination is corroborative with the safety data for combined oral contraceptives.