Phase III fezolinetant trial meets primary goal

Japanese drugmaker Astellas Pharma (TYO: 4503) has announced top-line results from the STARLIGHT 2 Phase III pivotal study for fezolinetant in Japan, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause, has met the primary endpoint.

VMS, characterized by hot flashes, sweating and night sweats, are common symptoms of menopause and can have a significant impact on women’s quality of lif;e.1

The study, which enrolled 410 Japanese women experiencing VMS associated with menopause demonstrated a statistically significant improvement in frequency of VMS from baseline to week 8 for fezolinetant 30mg and 45mg once daily versus placebo. Serious Treatment Emergent Adverse Events (TEAE) occurred in less than 4% of patients, and adverse events were consistent with the known safety profile.