(Reuters) – Evofem Biosciences Inc said on Monday its birth control gel showed effectiveness in preventing pregnancy in a late-stage study, paving the way for potential approval of the first hormone-free contraceptive gel and sending its shares up 17 percent before the bell.
The gel, Amphora, works by regulating vaginal pH within the normal range of 3.5 to 4.5, creating a hostile environment to sperm and certain viral and bacterial pathogens that can cause sexually transmitted diseases.
No serious side-effects were observed in the study, which evaluated about 1,400 healthy women belonging to the age group 18-35 years, Evofem said.
The company plans to resubmit the marketing application for Amphora in the second quarter next year.
If approved, Evofem plans to launch the gel in January 2020, providing a more convenient option than traditional birth-control methods such as pills and implants, the company said.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Maju Samuel