ella (ulipristal), a new contraceptive pill which offers to prevent the occurrence of accidental pregnancy upto five days after unprotected sex has been recommended for approval in US.
Once approved the contraceptive pill ella (ulipristal) will provide a welcome option to teenage girls and adult women to stop unplanned pregnancies with less concern as the currently available pills can prevent the chances of getting pregnant only upto 3 days after sexual intercourse.
ella is a new-generation emergency contraceptive, is based on ulipristal acetate, the first representative of a new class of compounds the Selective Progesterone Receptor Modulators (SPRMs).
Progesterone receptor modulating drugs interfere with the sex hormone progesterone, which is key to occurrence of pregnancy.
Ella’s class of drugs includes the abortion pill known as RU-486, or mifepristone, and sold as Danco Laboratories’ Mifeprex.
Mifeprex is usually given in combination with another drug to abort a pregnancy once it occurs.
However, the advantage of ella is it works by stopping the release of a woman’s egg for up to five days after unprotected sex. Egg or ovum released by the woman’s ovaries are inevitable for pregnancy.
Also clinical trial data using ella (ulipristal) showed that the pill has no significant side-effects. The most commonly reported side effects were nausea, headache and abdominal pain, according to the company and the FDA.
ella (ulipristal) study which involved more than 4000 women from the U.S. and Europe, is considered the largest development program ever conducted in the emergency contraceptive field.
Ulipristal acetate was approved in May 2009 by the European Commission for marketing as an emergency contraceptive within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. The product was launched in October 2009 and is marketed today in 22 European countries under the brand name ellaOne.
Girls or women who wish to prevent pregnancy after unprotected intercourse or contraceptive failure, she should take one tablet of ella orally as soon as possible, but not later than 120 hours (5 days).
ella (ulipristal) tablet can be taken with or without food. If vomiting occurs within 3 hours of Ella intake, another tablet should be taken.
ella (ulipristal) can be taken at any moment during the menstrual cycle.However, the user should ensure that they are not pregnant at the time of taking ella (ulipristal).
Safety and efficacy of ella (ulipristal) was only established in women 18 years and older.
The pills may reduce contraceptive action overtime. Therefore, after using
emergency contraception, it is recommended that subsequent acts of intercourse be protected by a reliable barrier method until the next menstrual period starts.
Women should not use ella again and again within the same menstrual cycle.
After ella consumption menstrual periods can sometimes occur earlier or later than expected by a few days.
Emergency contraception with ella does not prevent pregnancy in every case. No data is available on the efficacy of ella for women who have had unprotected intercourse more than 120 hours before ella intake.
In case of doubt, delay of more than 7 days in next menstrual period, abnormal
bleeding at the expected date of menses, or symptoms of pregnancy, pregnancy should be excluded by a pregnancy test, according to a company brochure.
ella is developed by HRA Pharma, a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide.
A pioneer in emergency contraception, the company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as contraception education in developing countries, to promote healthy management of drugs and diseases.