WASHINGTON – Federal health officials Friday approved a new kind of morning-after contraceptive that works longer than the current leading drug on the market.
The pill ella from HRA Pharma cuts the chance of pregnancy when taken up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of sex.
The Food and Drug Administration approved the drug Friday as a prescription-only birth control option. The ruling clears the way for U.S. sales of the drug, which has already been approved in Europe.
Morristown, N.J.-based Watson Pharmaceuticals will market the drug in the U.S. under an agreement with HRA. Watson said it will launch the pill in the fourth quarter.
Studies of ella by its manufacturer showed the drug prevented pregnancies longer and more consistently than Plan B.
In a head-to-head trial between the two drugs, women who took ella had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.
Plan B, made by Teva Pharmaceuticals, also is marketed in several generic versions. Unlike ella, Plan B and other generic versions are available without a prescription for women 17 years and older.
HRA Pharma did not request over-the-counter status for ella.
Ella uses the hormone progesterone to delay ovulation, a key step in the fertilization process.
Despite this, the drug has drawn criticism from anti-abortion groups who say it is closer to an abortion pill than an emergency contraception pill.
Groups including the Family Research Council argue the drug is chemically similar to the abortion drug mifeprestone, which can be taken to end a pregnancy up to 50 days into the gestation period. That drug has been associated with severe infections and bleeding after abortion. However, FDA reviewers reported no life-threatening medical side effects with ella.
The drug’s most common side effects included headache, nausea and abdominal pain, according to an FDA release.
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