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FDA Grants Approval of ella(R) for Emergency Contraception

Saturday, August 14, 2010 Drug News J E 4
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PARIS, August 13, 2010 HRA Pharma announced today thatthe US Food and Drug Administration (FDA) granted approval for ella(R)(ulipristal acetate) as a prescription-only emergency contraceptive indicatedfor use within 120 hours (five days) of unprotected intercourse or a known orsuspected contraceptive failure. ella is not intended for routine use as acontraceptive.

The approval is based on two Phase 3 studies that showed that ellasignificantly reduced the risk of pregnancy in women who used it afterunprotected intercourse. A progesterone agonist/antagonist that potentlyinhibits follicular rupture when taken just before ovulation is to occur,ella has been shown to be consistently effective when used up to five daysafter intercourse. Currently-marketed emergency contraceptives based onlevonorgestrel are labeled for use within 72 hours or three days ofintercourse.

"As a pioneer and a leader in the field of emergency contraception, HRAPharma is committed to providing women and their health care providers highlyeffective contraceptive options," said Erin Gainer, CEO of HRA Pharma. "ella,an effective and well-tolerated new generation emergency contraceptive,fulfills a significant and previously unmet need in this field by reducingpregnancy risk up to five days after intercourse."

The product will be launched and marketed in the US by HRA Pharma'spartner Watson Pharmaceuticals, Inc. The two companies announced theirlicense agreement earlier this year.

Ulipristal acetate has been marketed under the brand name ellaOne(R)since October 2009 in 22 European countries in the same indication. Asserving needs in reproductive health is a priority for HRA Pharma, thecompany plans to seek marketing approvals in countries worldwide.

Important Safety Information

The safety and tolerability of ella have been extensively evaluated andestablished. Among the more than 2,600 women who have received ella 30 mg inclinical trials, the most commonly reported adverse events in the open-labeland single-blind studies, respectively, were mild to moderate headache(18%/19%), nausea (12%/13%), abdominal and upper abdominal pain (15%/8%),dysmenorrhea (7%/13%), fatigue (6%/6%) and dizziness (5%/5%) - a profilesimilar to that of other available oral emergency contraceptives.

ella should not be used during an existing or suspected pregnancy, andwomen who become pregnant or complain of lower abdominal pain after takingella should be examined for the possibility of an ectopic pregnancy. Repeateduse of ella within the same menstrual cycle is not recommended, and because arapid return of fertility is likely following use of ella, routinecontraception should be continued or initiated as soon as possible. ella doesnot protect against HIV (AIDS) or other sexually transmitted infections.

About HRA Pharma

HRA Pharma is a privately-held European pharmaceutical company thatdesigns products, devices and supporting services in niche areas of healthand makes them available to doctors and patients worldwide. The companytargets therapeutic gaps in the areas of reproductive health andendocrinology, and uses innovative marketing solutions and socially-consciousprograms, such as contraception education in developing countries, to promotehealthy management of drugs and diseases. A pioneer in emergencycontraception, its product ulipristal acetate can be taken for up to fivedays after unprotected sexual intercourse and is the only product licensed inthe European Union (ellaOne(R)) and the U.S. (ella(R)) for this indication.Headquartered in Paris, France and with offices in Germany, Italy, Spain,France and the UK, HRA Pharma has built a strong network of R&D,manufacturing, distribution and NGO partners which enables it to satisfycritical patient needs and improve patient health in over 50 countries acrossthe globe. Visit http://www.hra-pharma.com for more information.

SOURCE HRA Pharma
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