Evofem Biosciences Inc (NASDAQ:EVFM) disclosed that the U.S. Food and Drug Administration has approved the company’s birth control gel, Phexxi.
The approval comes after being rejected by the FDA previously and years of clinical testing. Shares should see heavy volume and will could test double digits during the short trading week. The approval of the first non-hormonal contraceptive for women in decades is a big win for women around the world and shareholders of Evofem.
Phexxi, a non-hormonal vaginal gel, was approved by the FDA on Friday. One former FDA Division official had this to say, "During my 15-year career at the FDA, I participated in the review and approval of many sexual and reproductive health products, and I believe that Phexxi serves a true unmet need in contraception. Phexxi offers women protection and control - on their terms, and at their discretion - without the use of hormones."
Evofem CEO Saunra Pelletier said, "Women now have access to a non-hormonal contraceptive option that they control, on their terms to be used ONLY when they need it".
Phexxi is a vaginal gel that uses an on demand method and is the only hormone-free, female controlled prescription contraceptive gel. The gel, which can be administered an hour or less before intercourse, acts as a ph regulator to maintain a level between 3.5 and 4.5, an inhospitable environment for sperm.
Evofem expects to launch Phexxi in September with a concierge experience to target patients and healthcare providers.
EVFM shares added $1.36, or 27.3%, to $6.35.
