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New Analyses Indicate that Divigel(R) (estradiol gel) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes
Date:9/25/2008

- Transdermal Estrogen Analyses Continue to Show Benefits of Hormone

Therapy Use in Menopausal Women -

MAPLE GROVE, Minn., Sept. 25 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced that clinical abstracts featuring Divigel(R) (estradiol gel) 0.1% were presented at the North American Menopause Society's 19th Annual Meeting in Orlando, Florida. Divigel(R) is a transdermal estrogen therapy that was approved by the FDA in June 2007. It offers the lowest approved dose of estradiol gel for the treatment of moderate to severe hot flashes associated with menopause.

"These analyses indicate that Divigel(R) (estradiol gel) 0.1% is a valuable alternative for certain postmenopausal women with moderate to severe hot flashes," said Ronald Ackerman, MD, FACOG, CEO and principal investigator, Comprehensive Clinical Trials. "Analyses like these are crucial to further educate women about the benefits of hormone therapy for the management of hot flashes."

The first abstract presented at the meeting was a post-hoc analysis of 488 patients from a Phase III clinical trial to determine the effect of uterine status (intact, absent) plus Divigel(R) (1.0 g/day, 0.5 g/day, 0.25 g/day) compared to placebo on the change from baseline to week 12 in the frequency and severity of hot flashes. This study revealed that Divigel(R) is an effective treatment for the relief of moderate to severe hot flashes in postmenopausal women regardless of ovarian or uterine status.

The second abstract used the same patient population to evaluate the effect of age (<50 years, 50-59 years, greater than or equal to 60 years) and age plus Divigel(R) (1.0 g/day, 0.5 g/day, 0.25 g/day) combined compared to placebo on the change from baseline to week 12 in frequency and severity of moderate to severe hot flashes. This study revealed that Divigel(R) is an effective treatment for relief of hot flashes in postmenopausal women of any age; however, the e
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SOURCE Upsher-Smith Laboratories, Inc.
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