Watson Pharmaceuticals, Inc., announced that ella (ulipristal acetate) 30 mg, a novel oral emergency contraceptive, is now available for patients by prescription in the US. ella was approved by the US Food and Drug Administration (FDA) as safe and effective in helping to prevent unintended pregnancy for up to five days after unprotected intercourse (UPI) or a known contraceptive failure. ella delays ovulation for up to five days, which is also the length of time that sperm can live in the female genital tract, and can be taken at any time during the menstrual cycle.
"ella is the first truly new emergency contraceptive option for US women since 1999. It has a unique sustained efficacy profile and offers women an additional therapeutic option for preventing unintended pregnancy," said Fred Wilkinson, executive vice president, Watson Global Brands. "We are committed to making this innovative prescription-only emergency contraceptive option available to women as soon as possible and supporting the availability of ella in ways that emphasize education and access."
"We recognize that women who may seek emergency contraception rely on a number of channels for information, including the internet," Wilkinson continued. "We have built an informative website, ella-rx.com, that provides information on emergency contraception, discusses the appropriate use of ella, and offers insight into the prevention of unintended pregnancy," Wilkinson added.
The company noted that the ella launch will be phased over the next several months and will include physician educational initiatives, advocacy outreach and educational websites for consumers. Due to the urgent nature of emergency contraception, timely access to ella will be imperative. As such, stocking efforts have ensured the product will be available immediately by prescription at most retail pharmacies, clinics, as well as online via www.KwikMed.com, a licensed online pharmacy. Women can complete an extensive, physician-approved online diagnostic assessment and consultation, after which ella may be prescribed by fully licensed physicians in real time and delivered overnight to an address of the woman's choice.
ella is a progesterone agonist/antagonist emergency contraceptive and is proven effective in helping prevent pregnancies at certain stages of the menstrual cycle, including just before ovulation - the very time in a woman's cycle when the probability of pregnancy is highest. ella is effective in delaying ovulation for up to five days, which is also the length of time that sperm can live in the female genital tract. Currently available over-the-counter levonorgestrel-based emergency contraceptives are indicated for use within 72 hours of unprotected intercourse or contraceptive failure and their effectiveness in preventing pregnancy decreases over time.
Throughout its extensive clinical investigation, ella consistently demonstrated safe and effective pregnancy prevention. Among women who were administered ella within 72 hours of UPI, the observed pregnancy rate was 1.9%, significantly lower than the expected pregnancy rate (5.6%). Among women who were administered ella 48-120 hours post-UPI, the observed pregnancy rate was 2.2% -- again, significantly lower than the expected pregnancy rate (5.5%).
Among the more than 2,600 women who have received ella in clinical trials, the most commonly reported adverse events were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhoea (9%), fatigue (6%) and dizziness (5%) - a profile similar to that of other available oral emergency contraceptives.
ella should not be used during an existing or suspected pregnancy, and should not replace a regular method of contraception. ella may reduce the contraceptive action of regular hormonal contraceptive methods. Therefore, after use of ella, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur in that same menstrual cycle. Repeated use of ella within the same menstrual cycle is not recommended. ella is not indicated for termination of an existing pregnancy. ella does not protect against HIV (AIDS) or other sexually transmitted infections. and women who become pregnant or complain of lower abdominal pain after taking ella should be examined for the possibility of an ectopic pregnancy.
Ulipristal acetate has been available in Europe as an emergency contraceptive since October 2009, where it is marketed by its developer, HRA Pharma as ellaOne. Watson is the exclusive marketer of ella in the US under terms of a distribution agreement announced earlier this year.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.