Novel Oral Tx Dramatically Reduces Menopausal Flushing

March 2018, MedPage Today -- A neurokinin 3 receptor (NK3R) antagonist was effective at improving vasomotor symptoms without the need for estrogen exposure, both in the short and long-term, researchers reported.

The oral NK3R antagonist MLE4901 was able to reduce the frequency of hot flashes by 72% by day 3 of treatment versus baseline symptoms (95% CI -81.3% to -63.5%) and a 51% improvement in frequency with the oral treatment compared with those on placebo

This study included 37 women, ages 40-52, who reported seven or more hot flashes within 24 hours. Women received 4 weeks of the twice-daily 40 mg oral treatment, which works by blocking the hot flash receptor, followed by a 2-week washout period. Then the women switched to another 4-week intervention period, where they either received the treatment or placebo, whichever they did not receive during the first intervention period.

Frequency of hot flashes weren't the only improvement reported by women. Degree of severity for vasomotor symptoms also significantly improved with a 38% reduction from baseline by day 3, reaching a 44% reduction by day 28.

Level of bother improved by 39% on day 3 and continued to improve, reaching a 50% improvement by day 28. Women on the treatment also saw a significant improvement in the level of interference due to hot flashes, with a 61% improvement by day 3 and a 70% improvement by day 28.

"If larger, longer trials continue to show these excellent results of rapid reduction of hot flashes (both day and night flashes) and improvement in severity and bother of hot flashes, this may become the first specific, targeted, non hormonal, oral treatment of hot flashes," JoAnn Pinkerton, MD, executive director of The North American Menopause Society, told MedPage Today.

She added that confirmation in larger-scale trials could be "practice changing" for treatment of vasomotor symptoms, particular among postmenopausal women with a history of estrogen sensitive cancers, such as breast or uterine cancer, for whom hormone therapy would not be recommended.

"Relief of hot flashes is an important, unmet need for these women, as other nonhormonal therapies such as low dose antidepressants or gabapentin have not been as effective as hormone therapy at relieving severe hot flashes," she highlighted.

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