(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