You are here
Lower Dose Estrogen Treatment Approved by FDA
MADISON, N.J., April 25 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) approved a new low dose strength of the Company's estrogen therapy. Premarin® (conjugated estrogens tablets, USP) 0.45 mg contains 28 percent less estrogen than the standard 0.625 mg dose. Premarin 0.45 mg was approved for the treatment of moderate to severe vasomotor symptoms associated with menopause and the treatment of moderate to severe symptoms of vulvar and vaginal atrophy.
This is the second low dose postmenopausal hormone therapy product approval that Wyeth has received this year. Prempro™ (conjugated estrogens/ medroxyprogesterone acetate tablets) 0.45 mg/1.5 mg, was approved last month for use by women with a uterus to treat moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy. Wyeth expects to have Premarin 0.45mg and Prempro 0.45mg/1.5 mg available in early summer 2003.
"These approvals represent important new options for clinicians and women, and the availability of lower dose products will facilitate better individualization of therapy, particularly for new patients," says Victoria Kusiak, Vice President Global Medical Affairs, and North American Medical Director, Wyeth Pharmaceuticals.
The FDA, other health experts, and Wyeth 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 low dose postmenopausal hormone therapies over four years ago. Data supporting the efficacy and tolerability of Premarin 0.45 mg and Prempro 0.45 mg/1.5 mg are based on the Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) Study, a prospective, randomized, double-blind, placebo-controlled, multicenter trial of 2,673 healthy postmenopausal women (40 to 65 years of age). To date, these data have been the subject of five separate publications in peer-reviewed medical journals: four in Fertility and Sterility and one in the Journal of the American Medical Association (JAMA).
Postmenopausal estrogen therapy, which was first introduced more than 60 years ago, remains an important therapeutic option for menopausal women. In the U.S. alone, over 4,000 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 estrogen/hormone therapy is the only FDA-approved treatment indicated for the relief of menopausal symptoms.
These new low dose options, Premarin 0.45 mg and Prempro 0.45 mg/1.5 mg, now join the Wyeth family of hormone therapy products, which include Premarin 0.625 mg, Prempro 0.625 mg/2.5 mg, 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.
PREMARIN is used after menopause to reduce moderate to severe hot flashes and to treat moderate to severe dryness, itching, and burning in or around the vagina. PREMARIN 0.625 mg, 0.9 mg, 1.25 mg, and 2.5 mg is also approved to help reduce a woman's chances of getting osteoporosis (thin, weak bones).
PREMPRO 0.45 mg/1.5 mg 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/2.5 mg, PREMPRO 0.625 mg/5 mg, and PREMPHASE 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 0.625 mg, 0.9 mg, 1.25 mg, and 2.5 mg, PREMPRO 0.625 mg/2.5 mg, PREMPRO 0.625 mg/5 mg, or PREMPHASE solely for the prevention of postmenopausal osteoporosis.
In a clinical trial, commonly reported side effects for PREMARIN that were statistically different than placebo were leg cramps, vaginitis (vaginal inflammation) and vaginitis due to yeast, painful menstruation, and vaginal bleeding.
In a clinical trial, commonly reported side effects for PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg that were statistically different than placebo were breast pain, vaginitis (vaginal inflammation), vaginitis due to yeast, leg cramps, painful menstruation, vaginal spotting/bleeding, and breast enlargement. The most commonly reported side effects of 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.
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.
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.