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New Data: Efficacy and Responder Analyses of Divigel(R) (estradiol gel) 0.1 percent for the Treatment of Menopause
Date:6/30/2009

Data shows a very high percentage of women responded favorably to a bioidentical and FDA approved hormone therapy for hot flashes

MAPLE GROVE, Minn., June 30 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. presented the results of a secondary analysis to determine the response rates to three doses of transdermal Divigel(R) (estradiol gel) 0.1 percent at the recent 57th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) in Chicago. The objectives of this secondary analysis of a phase III efficacy trial were to determine the percent of postmenopausal women who achieved a greater than 50 percent reduction in the frequency of moderate to severe vasomotor symptoms (MSVMS), or hot flashes, and to assess the change from baseline in a quality of life (Kupperman) index score that evaluated various menopausal symptoms. Divigel(R) doses studied included 1.0 mg, 0.5 mg and 0.25 mg of estradiol/day - the lowest effective approved dose of estradiol available for the treatment of MSVMS. The analysis showed a significantly greater percentage of women in all treatment groups versus placebo experienced > / = 50 percent reduction in the frequency of MSVMS at week 12. In the Divigel(R) 1.0 mg estradiol/day dosing group, 90 percent of women reported at least a 50 percent reduction in the frequency of MSVMS. Additionally, at 12 weeks, each of the doses of Divigel(R) significantly reduced the severity of menopausal symptoms identified by a quality of life index score compared to placebo.

"These data further support the safety, efficacy and tolerability of Divigel(R) as a bioidentical and FDA-approved hormone therapy for the treatment of the symptoms of menopause," said Dr. William Koltun, a clinical investigator from the Medical Center for Clinical Research in San Diego, Calif. who presented the data at ACOG. "Divigel(R) is an important addition to the options for women and their physicians in the treatmen
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SOURCE Upsher-Smith Laboratories, Inc.
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