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FDA Approves Lower Dose Prempro (Conjugated Estrogens/ Medroxyprogesterone Acetate)

MADISON, NJ -- March 13, 2002 -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (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 the newest product from Wyeth, the leader in women's health with a long history of product innovation. Prempro 0.45/1.5 is part of a family of well-known products, which includes Premarin(R) (conjugated estrogens tablets, USP), Prempro 0.625/2.5 (conjugated estrogens/ medroxyprogesterone acetate tablets), Premphase(R) (conjugated estrogens/medroxyprogesterone acetate tablets), and Premarin(R) (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.

PREMARIN® (conjugated estrogens tablets, USP) is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning in or around the vagina; and to help reduce a woman's chances of getting osteoporosis (thin, weak bones).

PREMPRO(TM) (0.45 mg conjugated estrogens/1.5 mg medroxyprogesterone acetate tablets) is used after menopause in women with an intact uterus to reduce moderate to severe hot flashes and to treat moderate to severe dryness, itching, and burning in or around the vagina.

PREMPRO™ (0.625 mg conjugated estrogens/2.5 mg medroxyprogesterone acetate tablets), PREMPRO(TM) (0.625 mg conjugated estrogens/5 mg medroxyprogesterone acetate tablets), and PREMPHASE(R) (conjugated estrogens/medroxyprogesterone acetate tablets) are used after menopause in women with an intact uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning in or around the vagina; and to help reduce a woman's chances of getting osteoporosis (thin, weak bones).

PREMARIN VAGINAL CREAM is indicated in the treatment of atrophic vaginitis and kraurosis vulvae.

Premarin, Prempro, Premphase, and Premarin Vaginal Cream should be used for the shortest duration consistent with a woman's treatment goals and risks. If a woman does not have symptoms, non-estrogen treatments should be carefully considered before taking PREMARIN, PREMPRO 0.625 mg/2.5 mg, PREMPRO 0.625 mg/5 mg, or PREMPHASE solely for the prevention of postmenopausal osteoporosis.

The most commonly reported side effects of PREMARIN are hair loss, headache, and weight gain.

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.

The most commonly reported side effects of PREMARIN VAGINAL CREAM are vaginitis, pain, breast pain, and pruritus (itching).

Premarin, Prempro, Premphase, or Premarin Vaginal Cream should not be used if a woman has unusual vaginal bleeding, has or had cancer of the breast or uterus, had a stroke or heart attack in the past year, has or had blood clots, has liver problems, is allergic to any of the ingredients in PREMARIN, PREMPRO, PREMPHASE, or PREMARIN VAGINAL CREAM, or thinks she may be pregnant.

About Wyeth

Wyeth Pharmaceuticals has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

(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.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing, and commercialization, and economic conditions, including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patents, and other risks and uncertainties, including those detailed from time to time in Wyeth's periodic reports, including quarterly reports on Form 10-Q and the Annual Report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.


SOURCE: Wyeth Pharmaceuticals

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