- FDA (Food and Drug Administration) had approved first non-hormonal contraceptive vaginal gel for use as an on-demand method of contraception on 23 May 2020.
- The contraceptive gel, Phexxi is product of Evofem Biosciences Inc. It is composed of lactic acid, citric acid and potassium bitartarate. It works by maintaining vaginal pH within range of 3.5-4.5, an acidic environment which is not suitable for sperm.
- The gel should be applied in vagina immediately before or up to one hour before of each vaginal intercourse. If more than one vaginal intercourse occurs within one hour, an additional dose must be applied. It is not effective for prevention of pregnancy when administered after intercourse.
- The present contraceptive market is dominated by male condoms and female hormonal contraceptive pills which causes side effects like mood swings and nausea.
- The only non-hormonal contraceptive device in market is copper based intrauterine devices which are associated with bleeding and cramps.
- The failure rate for male condom is 13 %, 7% for hormonal pills and less than 1 % for intrauterine devices. Clinical trial of Phexxi had showed 13.7 % failure rate in preventing pregnancies.
- The most common side effects observed during clinical trial was vaginal itching and burning. More than 10 % of women participants experienced this.
- It is being studied for prevention of sexually transmitted diseases such as chlamydia and gonorrhea in women.
- The gel is expected to be available in September 2020.
References
- https://medicaldialogues.in/obstetrics-gynaecology/news/fda-approves-first-on-demand-vaginal-gel-for-contraception-66021?infinitescroll=1
- https://go.usa.gov/xw326
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