Phase III AMPOWER study of Amphora meets primary endpoint in contraception.- Evofem Biosciences.

Evofem Biosciences announced that its Phase III clinical trial of Amphora (L-lactic acid, citric acid, + potassium bitartrate) for the prevention of pregnancy, AMPOWER, successfully met its primary endpoint. AMPOWER assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women aged 18-35 years at 112 centers in the U.S. The primary endpoint of the study was the pregnancy rate over seven cycles of use (one cycle = 21-35 days) as assessed by the Kaplan-Meier statistical method.

Top-line data analysis demonstrates a cumulative pregnancy rate of 14.0% over seven cycles of use (95% CI 10.0, 18.0). This corresponds to an 86.0% efficacy rate (referred to as typical use), which meets the pre-determined endpoint of this clinical trial. In women who correctly used Amphora per study protocol, the cumulative pregnancy rate was 1.3% over seven cycles of use (95% CI 0.4, 2.1). This corresponds to a 98.7% efficacy rate. The results demonstrate that when Amphora is used as directed, the efficacy in which women can have confidence is similar to other frequently used contraceptive methods.

Overall in the AMPOWER study there were more than 24,000 acts of intercourse in which Amphora use was reported. Of these, Amphora was used as directed 88.9% of the time. There were minimal side effects reported by AMPOWER study participants, and there were no serious treatment-related adverse events reported.

Comment: after further data analysis the company plans to submit the Amphora NDA to the FDA in the second quarter of 2019. If approved, it plans to commercialize the first- in-class MVP-R for birth control in January 2020.