New Data on Managing Hot Flashes

By: Red Hot Mamas

Published: May 16, 2011

pristiq_news

Earlier last month at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) in Washington D.C., Pfizer announced results of a Phase 3 12-week efficacy sub-study. Data were presented, which found that PRISTIQ® (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women. Here is an excerpt from the press release.

PRISTIQ® (desvenlafaxine) Extended Release Tablets Shown To Significantly Reduce Number And Severity Of Moderate-To-Severe Hot Flashes Associated With Menopause

WASHINGTON, D.C., May 3 – Pfizer Inc. (NYSE: PFE) today announced results from a Phase 3 12-week efficacy sub-study, which found that PRISTIQ® (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women. The data were presented at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in Washington, D.C.

PRISTIQ, which is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults, is a non-hormonal therapy currently under review by the FDA for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause – commonly referred to as hot flashes and night sweats.

“Desvenlafaxine significantly reduced the number and severity of moderate-to-severe hot flashes among postmenopausal women compared with placebo, which is meaningful because up to 75 percent of women experience hot flashes associated with menopause,”1,[3] said JoAnn V. Pinkerton, M.D., lead author for the efficacy sub-study and Medical Director of Midlife Health Center and Professor of Obstetrics and Gynecology, University of Virginia.

Women can experience hot flashes associated with menopause for varying periods of time, typically ranging from six months to a few years.

“Pfizer is committed to women’s health and understands the impact that hot flashes and night sweats related to menopause can have on a woman’s life and the importance of having options to treat menopausal symptoms,” said Steven Romano, M.D., senior vice president and head, Medicines Development Group, Primary Care Business Unit, Pfizer. “If approved by the FDA for this indication, PRISTIQ will expand the range of effective treatment options available to help manage VMS in the United States.”

More About the Efficacy Sub-study

The efficacy sub-study of 365 patients was part of a year-long, double-blind, placebo-controlled safety trial conducted in the United States and Canada. Patients enrolled in the efficacy sub-study were required to have at least 7 bothersome moderate-to-severe hot flashes per day or 50 bothersome moderate-to-severe hot flashes per week at baseline.1 In the efficacy sub-study, desvenlafaxine met all four co-primary endpoints – the change from baseline in both the number and severity of moderate-to-severe hot flashes at week 4 and at week 12 (all p<0.001 versus placebo).

At week 4 of this efficacy sub-study, women in the PRISTIQ-treated group experienced a 55 percent reduction in hot flash frequency (average decrease of 6.5 hot flashes/day from a baseline mean of approximately 12 hot flashes/day) contrasted with a 31 percent reduction in hot flash frequency (average decrease of 3.6 hot flashes/day from a baseline mean of approximately 12 hot flashes/day) in the placebo group. At week 12, women in the PRISTIQ-treated group experienced a 62 percent reduction in hot flash frequency (average decrease of 7.3 hot flashes/day from a baseline mean of approximately 12 hot flashes/day) contrasted with a 38 percent reduction in hot flash frequency (average decrease of 4.5 hot flashes/day from a baseline mean of approximately 12 hot flashes/day) in the placebo group.

Women in the PRISTIQ-treated group also experienced a 20 percent reduction in the severity of their hot flashes contrasted with an 8 percent reduction in the placebo group at week 4 of this efficacy sub-study. At week 12, women in the PRISTIQ-treated group experienced a 25 percent reduction in the severity of their hot flashes contrasted with a 12 percent reduction in the placebo group.

During the 12-week efficacy sub-study, the most commonly reported adverse events were nausea, dry mouth, fatigue, constipation, diarrhea and somnolence.1 Ten percent of the PRISTIQ-treated patients and 3.7 percent of the placebo-treated patients discontinued the study early due to adverse events.1 A total of 2.5 percent of the PRISTIQ-treated patients and 8.4 percent of the placebo-treated patients discontinued due to lack of efficacy.

References

Pinkerton JV, Constantine G, Hwang E, Cheng RJ. Desvenlafaxine efficacy vs placebo for the treatment of menopausal vasomotor symptoms. Poster presented at: 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG); April 30 – May 3, 2011; Washington, D.C.

North American Menopause Society. Menopause glossary. http://www.menopause.org/glossary.aspx. Accessed February 23, 2011.

North American Menopause Society. Clinical issues. In: Menopause Practice: A Clinician’s Guide. 4th ed. Mayfield Heights, OH: North American Menopause Society; 2010:4-9.

More information on Hot Flashes and Menopause

Share this article
Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Email this to someonePrint this page