‘Revolutionary’ birth control gets green light
On Friday, US regulators approved a new kind of birth control being presented as an alternative to the oral contraceptive pill.
The gel, called Phexxi, comes in an applicator and is inserted into the vagina before having sex.
It contains common food additives such as lactic acid, citric acid and potassium bitartrate and is made by San Diego-based company Evofem Biosciences.
Phexxi works in a similar way to spermicides which block the entrance to the cervix and slow sperm down. Phexxi maintains the pH levels or acidity levels of the vagina at a rate that kills sperm upon its arrival.
The gel only needs to be used shortly before sex and unlike birth control pills, it doesn't contain hormones, which can cause side effects that some women find intolerable.
The medicine won't come cheap - around US $250-275 for a box of twelve applications, without insurance.
The FDA's approval of Phexxi is a victory for women's health, according to Saundra Pelletier, Evofem Biosciences' Chief Executive Officer.
'The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used ONLY when they need it,' Pelletier said in a statement.
In a study of 1400 women aged 18 to 35, Phexxi was about 86 per cent effective over seven menstrual cycles and around 34,000 acts of intercourse.
That effectiveness rate is an improvement on condoms, spermicides and "on-demand" contraceptives, but it's less effective than methods such as IUDs and implants.
Minor side effects included irritation and burning, but these were said to decline sharply after repeated use.
One doctor described Phexxi as a "terrific backup" method if used with a condom.
"If you have a guy who refuses to use a condom, this is a great option," added Dr. Lauren Streicher, medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause in Chicago.
Another advantage of Phexxi is that, although it was only approved by the FDA as a contraceptive, its testing indicates the gel also reduces the risk of infection by gonorrhoea and chlamydia.
The company plans to start a large patient study by year's end, then submit results to the agency for approval as a second product, for preventing those infections.
"If that pans out, that would be quite revolutionary," said Dr. Luu Ireland, a University of Massachusetts contraception specialist.
Originally published as 'Revolutionary' birth control gets green light