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FDA approves new low-dose Prempro -- efficacy comparable to leading hormone therapy

MADISON, N.J., March 13, 2003 -- Wyeth Pharmaceuticals announced that the FDA has approved a new lower dose of Prempro (conjugated estrogens [CE]/ medroxyprogesterone acetate [MPA] tablets), the most commonly prescribed brand of combination estrogen plus progestin therapy (also known as hormone therapy, or HT).

Low dose Prempro, containing 0.45 mg CE and 1.5 mg MPA, provides favorable tolerability and an efficacy profile comparable to the most frequently prescribed strength of Prempro, with 28 percent less estrogen and 40 percent less progestin. Low dose Prempro 0.45/1.5 is indicated for use by women with a uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats, and the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, such as vaginal dryness.

Data supporting the efficacy and tolerability of Prempro 0.45/1.5 are based on the Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) Study, a prospective, randomized, double-blind, placebo-controlled, multicenter trial of 2,805 healthy postmenopausal women (40 to 65 years of age) with a uterus. The Women's HOPE trial showed that Prempro 0.45/1.5 was as effective in treating vasomotor symptoms and vaginal atrophy as the most commonly prescribed dose of HT(1), with a low incidence of breakthrough bleeding or spotting(2).

"We are very pleased by the approval of this important new low dose option for postmenopausal symptomatic women," says Bernard Poussot, President, Wyeth Pharmaceuticals. "The approval comes just eight months after data from the Women's Health Initiative (WHI) were released, which led the FDA and other health experts to recommend that women take the lowest dose of postmenopausal hormone therapy for the shortest duration consistent with treatment goals and risks for the individual woman."

Wyeth began development of its lower dose postmenopausal hormone therapies over four years ago. Given the recent recommendations on HT use, it has become an even greater priority for Wyeth to make low dose Prempro 0.45/1.5 available as soon as possible. The company expects that the first product shipments will be made in early summer. Over the next several months, Wyeth anticipates additional approvals based on other dose and usage data from the Women's HOPE study.

"Low dose Prempro is an important new option for the treatment of menopausal symptoms," says Dr. Victoria Kusiak, Vice President of Global Medical Affairs and North American Medical Director for Wyeth Pharmaceuticals. "If symptoms are an issue, low dose Prempro will provide a new way to individualize therapy using a lower hormone dose."

Postmenopausal hormone therapy, which was first introduced more than 60 years ago, remains an important therapeutic option for menopausal women. In the U.S. alone, nearly 5,000 women a day enter menopause. For many women, menopausal symptoms are a very important health issue. Symptoms can disrupt a woman's daily activities at home or work, disrupt her sleep, contribute to fatigue, and interfere with intimacy. Postmenopausal hormone therapy is the only FDA-approved treatment indicated for the relief of menopausal symptoms.

Prempro 0.45/1.5 is part of a family of well-known products, which includes Premarin (conjugated estrogens tablets, USP), Prempro 0.625/2.5 (conjugated estrogens/ medroxyprogesterone acetate tablets), Premphase (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin (conjugated estrogens) Vaginal Cream. Currently taken by approximately 7.5 million women in the U.S. alone, these products are prescribed more often than any other brand of postmenopausal hormone therapy.

Important information about the Premarin family of products

What is the most important information a woman should know about Premarin (an estrogen mixture) or Prempro and Premphase (combinations of estrogens and a progestin)?

  • Estrogens increase the chances of getting cancer of the uterus. A woman should report any unusual vaginal bleeding right away while taking these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Her health care provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.

Using estrogens with or without progestins may increase a woman's chances of getting heart attacks, strokes, breast cancer, and blood clots. A woman and her health care provider should talk regularly about whether she still needs treatment with estrogens.

In clinical trials with Prempro 0.45 mg/1.5 mg, the only side effects reported significantly more frequently than with placebo were breast pain and irregular bleeding. Other side effects reported by greater than/equal to 10 percent of women receiving Prempro 0.45 mg/1.5 mg were headache, infection, pain, joint pain, and flu syndrome.

The most commonly reported side effects of Prempro 0.625 mg/2.5 mg, Prempro 0.625 mg/5 mg, and Premphase are postmenopausal bleeding, hair loss, and breast pain.

(1) Utian WH, Shoupe D, Bachmann G, et al. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril. 2001; 75: 1065-1079.

(2) Archer DF, Dorin M, Lewis V, et al. Effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate on endometrial bleeding. Fertil Steril. 2001; 75: 1080-1087.

Source: Wyeth Pharmaceuticals

Posted: March 2003