10/20/2021 2 Comments
I recently volunteered to take part in a market research study for a brand-new development on the horizon for perimenopausal and menopausal symptoms. The upcoming product appears to be a first-in-its-class medication to treat the vasomotor symptoms of this time of hormonal change – vasomotor meaning, in everyday language, hot flashes and night sweats.
I was excited and eager to contribute in some small way to this historic happening in the world of menopausal medicine. As a newly declared perimenopausal woman (who’s likely had symptoms for at least the past two years), I believe that advocacy, information, education and the availability of proven options are paramount for women dealing with the symptoms associated with the drop in estrogen and progesterone – insomnia, first-ever experiences of anxiety or depression, skin changes, potential bone loss and much more.
I am an ardent researcher in matters perimenopause and menopause. I read medical journal articles, clinical trial reports, mass-market stories, medical society websites and personal stories of brave women who’ve spoken openly about their own experience. So when I heard about this market research study being conducted on behalf of a pharmaceutical company, I knew I wanted to help.
So, here are the details, as best as I can divulge.
The name of the company behind this is not clear. The market research interview was performed by a third-party company working with the pharmaceutical company. As a result, I don’t know which pharma company plans to release this new product or when they may do so.
It’s going to address vasomotor symptoms. As the questions continued, it became clear that this new product is one I’ve already read about. It will be a new class of medication focused on treating hot flashes and night sweats in particular. It is a non-hormonal drug called fezolinetant that has either concluded or is in the final stages of pre-market trials.
This is important because, to date, the most common options to treat hot flashes and night sweats are the gold standard, hormone replacement therapy (HRT), followed by antidepressants. Most antidepressants, usually in the SSRI class (but sometimes in the SNRI class, too) are prescribed “off label” for the treatment of hot flashes. “Off label” means that a medication is being used for a clinical purpose other than what it was originally created to treat. Brisdelle ® is the only SSRI antidepressant actually created to treat vasomotor symptoms; indeed it is a low dose (7.5 mg) of the antidepressant Paxil (generic Paroxetine). Other antidepressants commonly offered to treat hot flashes are Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine) and Effexor (venlafaxine).
Some women choose antidepressants over HRT for various reasons, including a personal history of cancer, prior embolisms and outdated and disproven information about the risks of hormone therapy (See WHI Wrong on HRT). At the same time, antidepressants can come with their own side effects – results that for some women are worse than the condition they’re intended to treat. So there is certainly a need for an alternative effective medication.
The pharmaceutical company is trying to get the right language and terminology together. Most of the questions I was asked pertained to certain word choices, phrases and definitions that team must be considering. I was asked to weigh and rank various words, sentences and themes. What I recall most are two things:
It’s not clear if the medication will treat anything other than hot flashes or night sweats. Vasomotor symptoms was the central theme in the market research study. While the interviewer mentioned the impact of hot flashes and night sweats on quality of life, they did not state or imply that the new drug will treat other symptoms like mood changes, hair thinning, skin quality, vaginal dryness or any of the other dozens and dozens of potential perimenopausal and menopausal symptoms. So I think this drug must be laser-focused on night sweats and hot flashes alone. Of course, for some women, remediating those symptoms alone will have a major payoff in everyday life, so I don’t want to discount the benefit.
I bet the medication will be expensive, and most insurance companies won’t cover it. I have little factual basis for my claim here, but with many medications that are new to the market, they are prohibitively expensive for most people. And since they are new, and no generics are yet available, insurance companies may not cover it. Instead, I fear that women will want to try this new medication and won’t be able to because insurance only covers generics and / or they will route the woman to try an existing antidepressant used for that purpose instead. It may take years for the cost to come down or for there to be a widely available generic option.
So these are my takeaways for now. I will likely be part of a follow-up survey and may have even more to say about it as the drug gets ready for its official launch. I am glad there is progress being made in learning more about – and developing solutions for – the symptoms of perimenopause and menopause. By the time my daughters reach this phase of life, hopefully there will be a full menu of hormonal and non-hormonal options for them that they don’t have to fight tooth and nail to access.
The Real Peri Meno is devoted to all things perimenopause - the science, treatments, care, understanding, personal experiences, relationships, culture and more. The brain child of Keisha D. Edwards, The Real Peri Meno developed out of her own shock-and-awe experience with perimenopause and navigating the disjointed U.S. medical system in search of answers, support and relief.
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