Evofem’s birth control gel meets main study goal; shares rise

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(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

http://feeds.reuters.com/~r/reuters/healthNews/~3/Ybf1BmL65PQ/evofems-birth-control-gel-meets-main-study-goal-shares-rise-idUSKBN1OG17J

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