Phase 3 clinical trial shows long-term safety of menopausal vasomotor symptom therapy

Results from the phase 3 SKYLIGHT 4 clinical trial supported the long-term safety of a nonhormonal therapy for vasomotor symptoms of menopause, according to a press release from Astellas Pharma Inc.

The 52-week randomized, placebo-controlled, double-blind trial assessed the impact of fezolinetant — an investigational selective neurokinin 3 receptor antagonist — on endometrial health and its long-term safety and tolerability among 1,800 women seeking menopausal vasomotor symptom (VMS) relief.

“Based on our initial assessment, we are pleased with the outcome of the SKYLIGHT 4 study, which further characterizes the long-term safety of fezolinetant,” Nancy Martin, MD, PharmD, Astellas vice president and global medical head of medical specialties, said in the release. “With these fezolinetant data, we are hopeful that we will have the opportunity to deliver a first-in-class, nonhormonal treatment option for moderate to severe VMS associated with menopause.”

Healio previously reported on results from the SKYLIGHT 1 and 2 trials, which showed statistically significant reductions from baseline to week 12 in the frequency and severity of VMS among women who were assigned once-daily fezolinetant compared with placebo.

“Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area,” Genevieve Neal-Perry, MD, PhD, a member of the Fezolinetant Scientific Advisory Committee for Astellas and chair of the department of obstetrics and gynecology at University of North Carolina School of Medicine, said in the release. “I am excited by the potential of a new nonhormonal treatment option for women experiencing moderate to severe VMS associated with menopause.”