New oral drug treatment found highly effective in reducing menopausal hot flashes

A neurokinin 3 receptor (NK3R) antagonist (MLE4901) rapidly reduced hot flashes for short and long-term in postmenopausal women; thus, eliminating the need for estrogen therapy report researchers from Imperial College London. The study was published on March 12, ahead of print in North American Menopause Society Journal Menopause.

The neurokinin 3 receptor (NK3R) antagonist (MLE4901) is manufactured by Millendo Therapeutics Inc, based at Ann Arbor, Michigan.

Nearly 73% of postmenopausal women experience hot flashes with disruptive effects on activities of daily life along with increased use of hormonal medications. Although estrogen is crucial for the maintenance of bone and cardiovascular health during menopausal years, the maximum efficacy takes weeks to develop and women often discontinue the estrogen therapy for fear of side effects. 

In this phase 2, randomized, double-blind, placebo-controlled, single-center, crossover trial (NCT02668185) the researchers recruited 37 women between the age of 40 to 62 years, experiencing ≥7 HF/24 hours to receive either NK3R antagonist MLE4901 40mg bd for 4 weeks or placebo 40 mg bd in random order.

After a gap of 2 weeks, the women received another drug which they didn’t receive first time for4weeks.

The oral NK3R antagonist MLE4901 not only reduced the frequency of hot flashes by 72% by day 3 of treatment but also reduced the severity of HF by 38% (44% by end of 4 weeks) as compared to baseline symptoms (all P < 0.0001).

The interference due to HF was also reduced by 61% (70% by end of 4 weeks) and level of bother by 39% (50% by end of 4 weeks) at the end of 3 weeks of treatment as compared to a placebo.

Professor Waljit Dhillo, the lead author of the study said: “If a woman is having more than seven flushes a day and the drug is getting rid of three-quarters of them, that’s pretty life-changing.

“For day to day living and work, that’s a significant impact on quality of life. If we can reduce flushing by 73 percent it’s a game-changer for those patients,” he further added.

JoAnn Pinkerton, MD, executive director of The North American Menopause Society opined that further large-scale trials to bring the drug into clinical practice would be game-changing for women with a history of estrogen-dependent cancers like breast and uterine cancers.

"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 further added.

She also suggested looking at the long-term effect of this drug, specifically after continued use for 3-5 years as some women continue to experience HF for 15-20 years past menopause.

Abstract

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