Menopausal women now have more FDA-approved options for vasomotor symptoms than just a few years ago, according to JoAnn V. Pinkerton, MD.
During a presentation at The North American Menopause Society’s Annual Meeting, Pinkerton said clinicians now have the ability to utilize ospemifene (Osphena, Shionogi Inc.) for dyspareunia; combination bazedoxifene/conjugated estrogens (Duavee, Pfizer); or low-dose mesylate salt of paroxetine (Brisdelle, Noven Therapeutics) — the very first nonhormonal therapy indicated for hot flashes.
“These are alternatives for postmenopausal women with a uterus who need to avoid progesterone,” Pinkerton, a professor of obstetrics and gynecology and director of the Midlife Health Center at the University of Virginia, told Endocrine Today. “This provides new, much needed options for women. The FDA has done it; they’ve come up to bat.”
JoAnn V. Pinkerton
The first nonhormonal therapy
Two phase 3 trials previously demonstrated that low-dose mesylate salt of paroxetine (LDMP) reduced the mean weekly frequency and severity of vasomotor symptoms and was well tolerated among those assigned the drug.
“For women who are not candidates for oral HT, we have the first FDA-approved nonhormonal treatment for hot flashes,” Pinkerton said.
Pinkerton presented new data on the effect of sleep by LDMP compared with placebo.
“There was a decreased number of nighttime awakenings and improved duration of sleep; there were less sleep interferences and improved difficulty in sleeping,” Pinkerton said. “What was not [previously] published is there were no weight gains and no effect on libido.”
The number of nighttime awakenings due to vasomotor symptoms were reduced greater by LDMP compared with placebo at baseline, weeks 4, 12 and 24 (all P<.005), according to data.
Combination therapy and dyspareunia
Also new to the menopausal armamentarium is combination bazedoxifene/conjugated estrogens for the treatment of hot flashes, prevention of vaginal changes, bone loss without increasing breast tenderness, breast density, breast cancer, uterine stimulation or bleeding.
This tissue selective estrogen complex is a novel menopausal therapy that pairs a selective estrogen receptor modulator with one or more estrogens. Conjugated estrogens/bazedoxifene (CE/BZA) is one such therapy that has been shown to effectively treat vasomotor symptoms and preserve bone mineral density while protecting the endometrium in postmenopausal women with a uterus, according to data presented by Pinkerton.
The SMART clinical trials evaluated hot flashes, vaginal atrophy, dyspareunia and BMD. Pinkerton said the drug reduced hot flash frequency and severity; significantly improved vasomotor symptoms and sleep disturbances.
However, she said the mechanism of sleep improvements remains unclear.
Besides hot flashes, women with menopause also can develop dyspareunia. One new therapy for this indication is ospemifene, according to Pinkerton.
“For women who have vaginal dryness who are not candidates for either systemic or vaginal estrogen, we have a new serum which targets and improves vaginal pain with intercourse,” she said.