FDA approves longer-lasting morning-after pill
Source: Agencies |
August 15, 2010, Sunday
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Print Edition
Print Edition
HEALTH officials in the United States have approved a new type of morning-after contraceptive that works longer than the current leading drug on the market.
The pill ella from French maker HRA Pharma reduces the chance of pregnancy 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.
The Food and Drug Administration approved the drug as a prescription-only birth control option. The ruling clears the way for US sales of the drug, which already is approved in Europe.
New Jersey-based Watson Pharmaceuticals will market the drug in the US 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 unprotected sex.
Plan B is made by Teva Pharmaceuticals, an Israeli company, and also is marketed in several generic versions. Unlike ella, Plan B and other generic versions are available without a prescription for women 17 and older.
HRA Pharma did not request over-the-counter status for its drug.
Ella uses the hormone progesterone to delay ovulation, a crucial 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 emergency contraception.
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.
Abortion rights groups welcomed the approval.
The pill ella from French maker HRA Pharma reduces the chance of pregnancy 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.
The Food and Drug Administration approved the drug as a prescription-only birth control option. The ruling clears the way for US sales of the drug, which already is approved in Europe.
New Jersey-based Watson Pharmaceuticals will market the drug in the US 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 unprotected sex.
Plan B is made by Teva Pharmaceuticals, an Israeli company, and also is marketed in several generic versions. Unlike ella, Plan B and other generic versions are available without a prescription for women 17 and older.
HRA Pharma did not request over-the-counter status for its drug.
Ella uses the hormone progesterone to delay ovulation, a crucial 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 emergency contraception.
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.
Abortion rights groups welcomed the approval.
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