Genevieve Neal-Perry, MD, PhD, talks about the recent approval of fezolinetant (Veozah; Astellas Pharma) and her latest phase 3 research presented at the 2023 ACOG Annual Clinical and Scientific Meeting.
Genevieve Neal-Perry, MD, PhD:
Hi, my name is Genevieve Neal-Perry, MD, PhD. I'm a professor and chair at the University of North Carolina Chapel Hill.
Contemporary OB/GYN:
Can you tell us more about the recent approval of fezolinetant (Veozah; Astellas Pharma) for vasomotor symtpoms and what this approval means for ob-gyns?
Neal-Perry:
This is truly exciting because we haven't really had new options for patients and people who have hot flashes who can't or won't be able to use hormones. And s,o what's really unique about this medication is that its nonhormonal. It's an NK3 selective receptor antagonists. And it works specifically and uniquely at the neurons that cause hot flashes.
Contemporary OB/GYN:
How do you see this medicaition affecting the future of menopause treatments?
Neal-Perry:
For one, it's nonhormonal, so we don't worry about the same impact on breast and uterus. And in fact, we show that when inpatients or people using Veozah, they're not at increased risk for uterine cancer. So, we demonstrated that. We've also demonstrated that there's almost a 60% decrease in hot flashes, which is fantastic for people who have moderate to severe hot flashes. So, in our study, on average, people had 10 hot flashes a day. They had hot flashes at night, they had them in the morning, and then they saw a significant reduction as compared to a placebo.
Contemporary OB/GYN:
Can you tell us more about your presentation at ACOG?
Neal-Perry:
So, the presentation this afternoon is really about Veozah. What was the design of the study? What did the population look like? What were the outcomes? Really important about Veozah is that it had a very diverse population of people. Specifically, it had about 20% of non-Caucasian people, which is very rare. It had a significant group of individuals who identify as Black, 1 of the groups that have the worst hot flashes in terms of the burden for frequency as well as intensity. But also had people who are considered obese, another group that's often excluded from research, addressing hot flashes, and another group that's quite vulnerable and at risk in terms of having severe hot flashes. So, we go through that, we also go through data that shows what are some of the kind of what we call adverse events, and the frequency, and we show that the frequency of adverse events are equivalent or not significantly different than placebo. The most common adverse event was headache and COVID-19. Because the study happened during COVID-19.
Contemporary OB/GYN:
What are the top 3 takeawats from your presentation?
Neal-Perry:
The top 3 takeaways are that we actually have a new nonhormonal hormonal treatment that we can actually offer to people who cannot use hormones or who won't use hormones. So, this really creates a new opportunity to improve quality of life. There was a recent study by Mayo showing the financial impact of menopause. So, there's that opportunity to improve financial wealth for people that are impacted. And it's a 1 time dosing, which is important to know. And the other thing to know is that there are some things that you have to consider. Also, individuals who have known liver disease, or known kidney disease or end stage renal disease are not candidates for the drug.
Contemporary OB/GYN:
Any final thoughts?
Neal-Perry:
I'd like to say that, you know, it's about time, right? It has been a long time since we've had anything that has been as effective and nonhormonal as Veozah. When you consider half of the population can experience this, we're overdue. So, it's really exciting to be able to offer this to people that are impacted by hot flashes, and to know that there's relief available and that there are new options that we have in our pocket, as ob-gyns to use.
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