HRA Pharma announced today that the US Food and Drug Administration (FDA) granted approval for ella(R) (ulipristal acetate) as a prescription-only emergency contraceptive indicated for use within 120 hours (five days) of unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.
The approval is based on two Phase 3 studies that showed that ella significantly reduced the risk of pregnancy in women who used it after unprotected intercourse. A progesterone agonist/antagonist that potently inhibits follicular rupture when taken just before ovulation is to occur, ella has been shown to be consistently effective when used up to five days after intercourse. Currently-marketed emergency contraceptives based on levonorgestrel are labeled for use within 72 hours or three days of intercourse.
"As a pioneer and a leader in the field of emergency contraception, HRA Pharma is committed to providing women and their health care providers highly effective 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 reducing pregnancy risk up to five days after intercourse."
The product will be launched and marketed in the US by HRA Pharma's partner Watson Pharmaceuticals, Inc. The two companies announced their license 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. As serving needs in reproductive health is a priority for HRA Pharma, the company plans to seek marketing approvals in countries worldwide.
Important Safety Information
The safety and tolerability of ella have been extensively evaluated and established. Among the more than 2,600 women who have received ella 30 mg in clinical trials, the most commonly reported adverse events in the open-label and 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 profile similar to that of other available oral emergency contraceptives.
ella should not be used during an existing or suspected pregnancy, and women who become pregnant or complain of lower abdominal pain after taking ella should be examined for the possibility of an ectopic pregnancy. Repeated use of ella within the same menstrual cycle is not recommended, and because a rapid return of fertility is likely following use of ella, routine contraception should be continued or initiated as soon as possible. ella does not protect against HIV (AIDS) or other sexually transmitted infections.