Fezolinetant in Focus: Key Findings From the SKYLIGHT Trials

Author(s):

Ryan Haumschild, PharmD, MS, MBA, CPEL,JoAnn V. Pinkerton, MD, FACOG, MSCP

Key Takeaways

Fezolinetant's approval was based on SKYLIGHT 1, 2, and 4 trials, which were randomized, double-blind, and placebo-controlled.
The trials focused on women with moderate to severe vasomotor symptoms, evaluating fezolinetant's safety and efficacy.
Significant reductions in VMS frequency and severity were observed with fezolinetant compared to placebo.
Safety profiles were favorable, with adverse events similar to placebo, highlighting fezolinetant's potential as a non-hormonal treatment option.

Panelists discuss the methodologies of the SKYLIGHT 1, SKYLIGHT 2, and SKYLIGHT 4 trials that supported the approval of fezolinetant for moderate to severe vasomotor symptoms (VMS) and examine the key safety and efficacy results derived from these studies.

EP: 1.Understanding the Burden of Menopausal Vasomotor Symptoms

EP: 2.Barriers to VMS Treatment and Impact on Long-Term Health

EP: 3.Improving Access and Equity in VMS Treatment

EP: 4.Integrating VMS Treatment Into Comprehensive Women’s Health Management

EP: 5.Advances in Menopause Treatment: A Focus on the Neurokinin Pathway

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EP: 6.Fezolinetant in Focus: Key Findings From the SKYLIGHT Trials

Video content above is prompted by the following:

(SMITH) The approval of fezolinetant for moderate to severe VMS was based on the SKYLIGHT 1, SKYLIGHT 2, and SKYLIGHT 4 trials. Briefly describe the methodology of these studies.
(FIFFICK) What were the key safety and efficacy results from the SKYLIGHT studies?