Menopausal women who suffer from a common physical problem – so common it may impact 80 percent of them – will soon have a safer treatment to consider. And I’m proud and humbled to have authored the pivotal research study data leading to this breakthrough that has just been published in the journal Menopause.
A little background first: up to now the FDA has only approved treatment that is hormone-based to relieve hot flashes and night sweats associated with menopause. Considering that those symptoms are reported to be the most bothersome aspects of menopause, significantly affecting quality of life, one type of treatment that is not ideal for many women has been terribly limiting. For a variety of reasons, hormone-based therapy can carry certain risks for significant groups and the pervasiveness of symptoms makes it clear that the need exists for other options. I am thrilled that our work has produced such an option.
A product called Brisdelle is a new, already FDA-approved product that is about to be introduced to the post-menopausal health marketplace. It is unique as the first and up to now, only non-hormonal treatment for the most pervasive of what’s known as vasomotor symptoms (VMS) – night sweats and hot flashes. Clinical trials had shown that some drugs commonly used to treat depression and other psychiatric issues could be helpful, but further study was needed.
It was needed because studies released about ten years ago had pointed to some risk concerns for hormone-based treatments that made patients and clinicians reluctant. For a couple of years, prescriptions for the hormone therapy dropped drastically, leaving many patients without a viable option for treatment, and making it clear that a large group of those impacted simply chose to suffer through the symptoms, which can be severe. Alternative therapies gained some attention in popular media, but without the right kind of research and controls, additional risks were identified.
Our team studied the effects of the specific kinds of drugs designed for depression but in smaller doses, now known as LDMP treatment. The research followed standard protocols, involving nearly 600 participants in periods of up to six months. We were able to conclude that the treatment is safe, well tolerated and effective in reducing the frequency and severity of moderate to severe VMS symptoms due to menopause. The study also made evident that benefits persisted over time.
The results make it clear that LDMP treatment, now approved and on the market as Brisdelle, is an effective non-hormonal option for women and their health providers who need an alternative to estrogen-based therapies for this highly common problem.
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