Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Musculoskeletal | Obstetrics/Gynecology (Women’s Health) | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Watson Pharmaceuticals
Approval Status: Approved April 2002
Treatment Area: Postmenopausal osteoporosis, Vasomotor menopausal symptoms
Alora is an estrogen replacement therapy system approved for the
prevention of postmenopausal osteoporosis. In 1996, Alora was
approved for the treatment of moderate-to-severe vasomotor
menopausal symptoms, specifically hot flashes. The Alora patch is
thin, flexible and virtually transparent when worn on the skin. The
patch can be placed on the abdomen, hip or buttock and is available
in four dosage strengths. It is applied twice weekly and is worn
continuously for three or four days.
Osteoporosis is a thinning of the bones that makes them weaken
and more prone to breakage. Women who undergo menopause at an early
age, are thin, smoke or have a family history of osteoporosis are
more likely to develop this debilitating disease.
Approval of Alora is supported by a double-blind,
placebo-controlled trial involving 268 postmenopausal women who
experienced an average of at least 60 moderate-to-severe hot
flashes during the screening period. At weeks four and 12, Alora
was seen to be statistically better than placebo at relieving the
frequency and severity of vasomotor symptoms.
Alora was also tested in clinical trials in 355 hysterectomized,
non-osteoporotic women to measure the drug's effect on bone
mineral density (BMD). Alora was shown to increase lumbar spine BMD
statistically better than placebo.
Adverse events associated with the use of Alora may include (but
are not limited to) the following:
- Breast tenderness or enlargement
- Retention of excess fluid
- Vaginal spotting or bleeding
Mechanism of Action
Alora (estradiol) is a transdermal system designed to deliver
estradiol, a human estrogen. Estrogens bind to nuclear receptors in
estrogen-responsive tissues and modulate the pituitary secretion of
the gonadotropins luteinizing hormone and follicle stimulating
hormone through a negative feedback mechanism. Estrogen replacement
therapy acts to reduce the elevated levels of these hormones seen
in postmenopausal women.
The skin metabolizes estradiol only to a small extent compared
to orally adminstered estradiol, which is rapidly metabolized into
estrone, leading to higher circulating levels of estrone than
estradiol. Transdermal administration then, produces therapeutic
estradiol levels with lower levels of estrone and requires smaller
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