The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for E4/DRSP (estetrol and drospirenone; Mayne Pharma) for the prevention of pregnancy.
The novel combined oral contraceptive pill includes estetrol 15mg (E4) and drospirenone 3mg (DRSP). Estetrol is a native estrogen with selective action in tissues; it has been observed to have minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters. Mayne’s manufacturing partner Mithra will be responsible for synthesizing E4 for the product.
The application is supported by data from 2 multicenter, open-label, single-arm phase 3 studies (E4 FREEDOM EU/RU and US/Canada) that evaluated the safety, acceptability, efficacy, and cycle control of E4/DRSP in more than 3725 women aged 16 to 50. The primary end point was contraceptive efficacy as measured by the number of on-treatment pregnancies per 100 women per 12 months of exposure among the 16 to 35-year-old participants at study entry.
Findings from both studies showed that E4/DRSP met the primary end point. For the EU/RU study, the Pearl Index (PI) was 0.45 (95% CI, 0.19-1.09) among women 18-35 years of age, and 0.28 (95% CI: 0.09; 0.86) for the overall population (18-50 years of age). For the US/Canada trial, the PI was 2.41 (95% CI, 1.56-3.54) among women 16-35 years of age, and 2.30 (95% CI, 1.53-3.33) for the overall population (16-50 years of age).
The FDA is expected to complete its review in the first half of 2021.
“This is another important milestone for E4/DRSP and brings us one step closer to providing women in the US with a new contraceptive that we believe will be effective, safe and well tolerated,” said Mayne Pharma’s CEO Scott Richards. “In parallel, we continue to advance our US commercial strategy and infrastructure to ensure we are well positioned to support the potential launch of E4/DRSP in the first half of calendar 2021.”