The first graduated Estrophasic oral contraceptive cleared for marketing by the FDA.

MORRIS PLAINS, N.J.--(BUSINESS WIRE)--October 10, 1996--

Parke-Davis' Estrostep(R) (norethindrone acetate and ethinyl estradiol tablets) is only graduated Estrophasic(TM) OC

Estrostep(R), the first and only graduated Estrophasic(TM) oral contraceptive, was cleared for marketing by the U.S. Food and Drug Administration, Warner-Lambert Company announced today. The patented Estrophasic regimen was developed by Parke-Davis, a division of Warner-Lambert.

As the only graduated Estrophasic OC, Estrostep offers healthcare providers and women a new approach to low estrogen dosing. Other birth control pills usually contain a constant dose of estrogen and progestin, or change the dose of progestin throughout the cycle. Estrostep is the only oral contraceptive to combine low, gradually increasing amounts of estrogen (20, 30, 35 mcg ethinyl estradiol) with a low, constant dose of progestin (one mg norethindrone acetate). When used as directed, Estrostep is greater than 99% effective in preventing pregnancy, as are all other combination OC's.

"Estrostep represents a new approach to oral contraceptive dosing options," said Jean Rowan, M.D., senior director, Clinical Research, Parke-Davis. "Estrostep offers excellent contraceptive efficacy with a low estrogen dose. Clinical study results demonstrated high patient acceptance and good cycle control."

While both estrogen and progestin play a role in the efficacy of combination OCs, the estrogen component also contributes to maintaining menstrual cycle control. Clinical studies of Estrostep show that its unique graduated low estrogen doses are sufficient to provide good endometrial support. Few women in these studies discontinued Estrostep due to missed periods and breakthrough bleeding. These particular complaints are frequent among women who are trying the pill for the first time.

Early generation pills contained doses of estrogen as high as 150 mcg. Studies linking high doses of the hormone to adverse effects have resulted in progressive reduction of estrogen content, leading to today's low-dose pills. The most common pill prescribed today contains a constant 35 mcg estrogen dose.

With Estrostep, graduated amounts of estrogen are introduced into the woman's body in three phased-in doses during each menstrual cycle: 20 micrograms (mcg) of estrogen (ethinyl estradiol) for the first five days, 30 mcg for the next seven days, and 35 mcg for the last nine days, for a total of 21 days. Estrogen and progestin are stopped for the remaining seven days of the cycle, resulting in a woman's monthly menstrual period. The 28-day pill pack will contain seven inactive tablets to help women maintain their regimen.

In a comparative clinical study involving more than 1,200 women (769 receiving Estrostep), Estrostep was shown to have a high degree of patient acceptance, with a side effect profile comparable to other low-dose OCs. Estrostep demonstrated cycle control clinically comparable to a 30 mcg monophasic OC -- in fact, only 0.3% of women on Estrostep dropped out due to breakthrough bleeding.

Estrostep, like all oral contraceptives, may provide several noncontraceptive health benefits including: lower incidence of ovarian cysts, lower incidence of pelvic inflammatory disease, reduced likelihood of developing cancer of the ovaries and cancer of the lining of the uterus, more regular periods, lighter menstrual flow and less menstrual discomfort.

OCs are also associated with side effects. Nausea, vomiting, and breakthrough bleeding are common side effects that may subside within the first three months of use. Clinical studies with Estrostep showed that weight gain and nausea each caused fewer than one percent of women to withdraw from therapy.

Oral contraceptives are not appropriate for all patients. The use of oral contraceptives is associated with minor as well as serious adverse side effects, such as increased risk of myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease. The risk of serious morbidity and mortality is very small in healthy women without underlying risk factors. It is important to note that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Women who use oral contraceptives should be strongly advised not to smoke.

Estrostep is expected to be available in January 1997 and will be packaged in a discreet, patented, "credit-card" pack.

Parke-Davis, a division of Warner-Lambert Company, is devoted to discovering, developing, manufacturing and marketing quality pharmaceutical products. Its central research focus is on heart disease, diabetes, stroke, anti-infectives, central nervous system, cancer and women's healthcare. Warner-Lambert is a worldwide company employing approximately 37,000 people, and along with Parke-Davis is headquartered in Morris Plains, N.J.

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