Treatment-emergent adverse events (TEAEs) were also observed during the study, occurring in 37% of fezolinetant 30 mg, 43% of 45 mg, and 45% of placebo participants. "As a healthcare provider, I truly understand the burden of VMS due to menopause on my own patients, and I'm really excited about this potential new nonhormonal treatment option to help women experiencing moderate to severe VMS." "The SKYLIGHT 1 study showed that women receiving fezolinetant experienced a reduction in the frequency and severity of VMS and improvements in quality of life over the one-year treatment period," said Genevieve Neal-Perry, MD, PhD, chair of the UNC School of Medicine Department of Obstetrics and Gynecology. Additionally, investigators observed these improvements as early as week 1 and were maintained throughout the 52-week study period. In the study, fezolinetant met the 4 coprimary endpoints, with both the 30 mg and 45 mg doses achieving a statistically significant improvement from baseline in VMS frequency and severity at 4 and 12 weeks vs placebo. "This manuscript, which provides further insights into the safety and effectiveness of fezolinetant, reinforces Astellas' commitment to turning innovative science into value for patients."
HOT FLASHES COVID TRIAL
"This publication of the SKYLIGHT 1 study is another important report of a phase 3 randomized trial assessing the utility of an investigational nonhormonal agent, fezolinetant, that targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS due to menopause, and we are honored to see it published in The Lancet," said Ahsan Arozullah, MD, MPH, senior vice president and head of development therapeutic areas at Astellas. 1įezolinetant is an investigational oral, nonhormonal, selective neurokinin-3 (NK3) receptor antagonist currently being studied as a potential treatment for moderate to severe vasomotor symptoms (VMS) due to menopause. Just sucks that this is a surprise side effect it seems for some of us.Astellas Pharma has announced positive data from its phase 3 SKYLIGHT 1 (NCT04003155) study of fezolinetant, which was recently published in The Lancet. I'd rather have dizziness than be worse off with COVID. I, like many other here, am glad I got my second COVID vaccine dose.
HOT FLASHES COVID UPDATE
I will continue to update here on my progress to hopefully give others a sense of what might happen. My PCP thinks this should "blow over" in a few days and I hope he's right. So, I'm going on Day 3 of vertigo and I'm now 10 days out from my second Pfizer dose. I've tried doing the Epley and Foster maneuvers repeatedly to try to "re-align" the crystals in my ear but still spinning today (albeit much less so than I was on the weekend.) anyway.they gave me Meclizine (only really just makes me tired so stopped taking it). The vomiting and dizziness was so bad it landed me in the ER (wish I had known these were almost "normal" side effects for some). But then as the day went on I started to feel more and more dizzy. Drank some water and thought all would be fine. Felt completely fine the rest of the week until this past Saturday - 7 days after my 2nd Pfizer shot - and had a couple dizzy spells. Lymph nodes were swollen in my arm pits and aches eventually went away by Tuesday. Then got my second dose last Saturday, March 27th and 14 hours after my jab, I started feeling crappy.chills, aches, etc. Got my first Pfizer shot back in early March. Figured I'd chime in as well as I've found it so helpful to read others' posts.
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