Evofem Biosciences Inc. believes it can offer a new contraception alternative to women that will avoid the side effects and risks of hormonal products and offer on-demand use as a vaginal gel based on Phase III data for Amphora that show 86% efficacy in preventing pregnancy during typical use and 98.7% efficacy when users applied the product as directed. While the latter number is more impressive, the former will be the basis for the labeling claim Evofem will seek from the US FDA.
The San Diego-based women’s health company reported top-line data Dec. 17 for Amphora showing that it met the primary endpoint...
