New contraceptive drug gains US administrative approval

Saturday October 11, 2003

An "extended-cycle" oral contraceptive that reduces the number of periods from 13 to 4 per year has been approved the U.S. Food and Drug Administration. Clinical trials have found "SEASONALE" prevents pregnancy and has a comparable safety profile to a more traditional oral contraception. The new drug is designed to provide greater choice for women deciding on oral contraception and will be available on prescription in the States at the end of October 2003.

Barr Laboratories' SEASONALE is a a 91-day regimen taken daily as 84 tablets (0.15 mg levonorgestrel and 0.03 mg ethynyl estradiol) followed by 7 inactive tablets. Currently available oral contraceptives, which utilise the same well-established components, are based on a 28-day regimen.

A recently published Roper study cited in the Barr press release found that
when given the choice, nearly two-thirds of women would be interested
in reducing their number of periods to 4 times per year.

Barr also point out the when prescribing SEASONALE, the convenience of fewer periods should be weighed against the inconvenience of increased intermenstrual
bleeding and/or spotting.

It is estimated that more than 16 million women currently take oral contraceptives in the United States and in Australia 66.7% of all women used contraception according to ABS data from the mid-nineties, with the largest proportion - 40% - using the contraceptive pill.