Evofem's gel first non-hormonal contraceptive to get approval in over 30 years

By Dania Nadeem (Reuters) - Evofem Biosciences Inc's birth control gel received the U.S. Food and Drug Administration's approval on Friday, making it the first non-hormonal contraceptive for women in over three decades, sending its shares up 3.6%.

Reuters May 23, 2020 02:11:07 IST
Evofem's gel first non-hormonal contraceptive to get approval in over 30 years

Evofems gel first nonhormonal contraceptive to get approval in over 30 years

By Dania Nadeem

(Reuters) - Evofem Biosciences Inc's birth control gel received the U.S. Food and Drug Administration's approval on Friday, making it the first non-hormonal contraceptive for women in over three decades, sending its shares up 3.6%.

The company said earlier in May it was looking to price the contraceptive gel, Phexxi, between $250 and $275 for a box of 12 packs.

Phexxi's launch will, however, be delayed to the first week of September due to the disruptions caused by the coronavirus pandemic, the company said.

The gel is a rare new addition to the $5.5 billion U.S. contraceptive market, which is dominated by male condoms and hormonal birth control pills for women, known to cause a host of side effects such as bleeding between periods, mood swings and nausea.

The only non-hormonal contraceptive in the market has been the copper-based intrauterine devices, such as Cooper Surgical's ParaGard, which are often associated with bleeding and cramps, causing many to remove the implants within the first year.

The failure rate for male condoms is 13%, for hormonal pills it's 7% and less than 1% for intrauterine devices, according to the U.S. Centers for Disease Control and Prevention.

Clinical trials have found that Phexxi, which works by creating a hostile environment for the survival of sperm, has a 13.7% failure rate in preventing pregnancies.

The gel could bring in peak sales of $500 million by 2030, according to HC Wainwright analyst Raghuram Selvaju.

Phexxi, to be applied in the vagina using an applicator up to one hour before sex, has also been found to increase sexual satisfaction in female trial participants, likely due to the lubrication provided by the gel.

It is being studied for prevention of sexually transmitted diseases such as chlamydia and gonorrhea in women.

(Reporting by Dania Nadeem, Saumya Sibi Joseph and Trisha Roy in Bengaluru; Editing by Shinjini Ganguli)

This story has not been edited by Firstpost staff and is generated by auto-feed.

Updated Date:

TAGS:

also read

France, Germany to agree to NATO role against Islamic State - sources
| Reuters
World

France, Germany to agree to NATO role against Islamic State - sources | Reuters

By Robin Emmott and John Irish | BRUSSELS/PARIS BRUSSELS/PARIS France and Germany will agree to a U.S. plan for NATO to take a bigger role in the fight against Islamic militants at a meeting with President Donald Trump on Thursday, but insist the move is purely symbolic, four senior European diplomats said.The decision to allow the North Atlantic Treaty Organization to join the coalition against Islamic State in Syria and Iraq follows weeks of pressure on the two allies, who are wary of NATO confronting Russia in Syria and of alienating Arab countries who see NATO as pushing a pro-Western agenda."NATO as an institution will join the coalition," said one senior diplomat involved in the discussions. "The question is whether this just a symbolic gesture to the United States

China's Xi says navy should become world class
| Reuters
World

China's Xi says navy should become world class | Reuters

BEIJING Chinese President Xi Jinping on Wednesday called for greater efforts to make the country's navy a world class one, strong in operations on, below and above the surface, as it steps up its ability to project power far from its shores.China's navy has taken an increasingly prominent role in recent months, with a rising star admiral taking command, its first aircraft carrier sailing around self-ruled Taiwan and a new aircraft carrier launched last month.With President Donald Trump promising a US shipbuilding spree and unnerving Beijing with his unpredictable approach on hot button issues including Taiwan and the South and East China Seas, China is pushing to narrow the gap with the U.S. Navy.Inspecting navy headquarters, Xi said the navy should "aim for the top ranks in the world", the Defence Ministry said in a statement about his visit."Building a strong and modern navy is an important mark of a top ranking global military," the ministry paraphrased Xi as saying.