Once-a-week low-dose estrogen replacement skin patch from Parke-Davis cleared for marketing by FDA.

MORRIS PLAINS, N.J.--(BUSINESS WIRE)--Dec. 5, 1996--

FemPatch(TM) (estradiol transdermal system) offers a new option

for relief of menopausal symptoms

FemPatch(TM), an innovative, low-dose transdermal estrogen replacement system for the treatment of menopausal symptoms, was cleared for marketing by the U.S. Food and Drug Administration, Warner-Lambert Co. announced today.

FemPatch was co-developed by Parke-Davis, a division of Warner-Lambert, and Cygnus Inc., who will manufacture the product.

Using a low, 0.025 mg. dose of 17 beta-estradiol (a natural form of estrogen) in a thin, flexible once-weekly patch, FemPatch provides highly effective relief of vasomotor symptoms such as hot flashes and night sweats. In clinical trials, the vasomotor symptom relief of FemPatch was comparable to that achieved with a 0.05 mg. transdermal dose of 17 beta-estradiol.

FemPatch treats moderate to severe vasomotor menopausal symptoms using a patented matrix system that delivers estradiol through the skin in a consistent, low dose, reaching maximum blood levels within 24 hours and then maintaining constant blood levels for seven days. Clinical studies with FemPatch showed a low incidence of discontinuation due to skin effects (3%) or adhesion failure (less than 2%). Overall, discontinuation due to adverse events for FemPatch (2.8%) was comparable to placebo (2.8%).

Transdermal estrogen replacement systems currently on the market all contain the active ingredient 17 beta-estradiol in doses ranging from 0.0375 mg. to 0.1 mg.

"FemPatch delivers a 0.025 mg. daily dose of estradiol, giving women and their health care providers a new low-dose option for the treatment of moderate to severe vasomotor menopausal symptoms," said Jean Rowan, M.B. Ch.B., senior director, Clinical Research Department, Parke-Davis Pharmaceutical Research Division. "Physicians who have menopausal patients requiring low-dose estrogen will find FemPatch to be a desirable choice."

There are approximately 15 million women in the U.S. between the ages of 45 and 55, the typical age range for menopause. Menopause, characterized by the cessation of menstruation, can result in vasomotor symptoms ranging from multiple hot flashes during the day to numerous nighttime flashes, or "night sweats."

In clinical trials, FemPatch was shown to effectively reduce vasomotor symptoms by consistently delivering a nominal 0.025 mg. dose of estradiol. Two independent, 12-week, double-blind, placebo-controlled studies conducted with 324 surgically or naturally menopausal women, with moderate to severe vasomotor symptoms (a mean of 80 hot flashes per week and a range of 56-140 hot flashes per week), showed that FemPatch significantly reduced the number of hot flashes. By week 12, hot flash frequency decreased from 80 hot flashes to 13 per week -- a reduction of 84%. Reduction of hot flashes was significant as early as week two in some treatment groups, and by week three in all treatment groups.

FemPatch is a translucent, skin-like, rectangular-shaped laminated matrix system composed of three distinct layers. The recommended starting dose of FemPatch, when initiating estrogen replacement therapy in the management of vasomotor symptoms of menopause, is one patch every seven days. The buttocks is the preferred site of FemPatch application.

As with other estrogen replacement therapies, FemPatch may not be suitable for all patients and should not be used by women with any known or suspected pregnancy, breast cancer or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active thrombophlebitis; or thromboembolic disorders.

Side effects with FemPatch are similar to those seen with other estrogen replacement therapies. As with all estrogen products, there are possible common side effects such as: headache, nausea, abdominal cramps, fluid retention, irregular bleeding, breast tenderness or increase or decrease in weight. Estrogens also have been reported to increase the risk of endometrial carcinoma in postmenopausal women.

Parke-Davis, a division of Warner-Lambert Co., 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.

Full prescribing information is available. Call Wendy O'Donnell, 212/878-4779.

CONTACT: Ketchum Public Relations 

Peggy Hayes, 212/878-4779

Colleen Murphy, 212/878-4690

or

Warner Lambert, Media Relations

Stephen J. Mock, 201-540-6696

Jeffrey Baum, 201/540-2145

or

Warner Lambert, Investor Relations 

George Shields, 201/540-6916

John Howarth, 201/540-4874