HomeInvesting NewsAstellas States Fezolinetant Safety Information for Treating Menopausal Symptoms Over a Year

Astellas States Fezolinetant Safety Information for Treating Menopausal Symptoms Over a Year

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In a clinical investigation, the effectiveness and safety of a 30 mg dosage for the treatment of menopausal vasomotor symptoms (VMS) were assessed.

Astellas Pharma Inc. (OTCPK:ALPMF)

Data from a phase 3 trial of Astellas Pharma’s (OTCPK:ALPMF) oral medication Fezolinetant to treat moderate to severe vasomotor symptoms (VMS) related to menopause in women in mainland China were released

Clinical Trials in Phase 3 for MOONLIGHT

The goal of MOONLIGHT 1TM (NCT04234204) is to examine the effectiveness and security of Fezolinetant for the treatment of moderate to severe VMS related to menopause in Asian women. The first 12 weeks of the study are double-blinded and placebo-controlled, and then there is a 12-week non-controlled extension therapy period. At approximately 60 sites in mainland China, Korea, and Taiwan, 302 women with moderate to severe menopausal VMS were enrolled. The incidence and severity of adverse events (AEs), which were largely similar to earlier phase 3 studies of Fezolinetant, are the primary objectives of the 52-week study, known as MOONLIGHT 3.

Night sweats and VMS, often known as hot flashes or flushes, are typical menopause symptoms. The experiment included 150 women taking 30 mg of Fezolinetant once daily.

According to Ahsan Arozullah, senior vice president and head of Development Therapeutic Areas at Astellas, “the topline results from the MOONLIGHT 3 research are highly positive and, upon initial analysis, further demonstrate the long-term safety of Fezolinetant.”

As per Astellas, the outcome has no bearing on the projected financial results for the current fiscal year, which ends March 31, 2023. 

Fezolinetant

An investigational oral, nonhormonal medication called Fezolinetant is now being tested in clinics to treat moderate to severe vasomotor symptoms (VMS) linked to menopause. The business stated that a new drug application for Fezolinetant to treat moderate to severe VMS related to menopause is now being reviewed in the United States. Fezoletant had succeeded in the primary objective of a phase 3 trial known as SKYLIGHT 4 but had failed in different phase 3 research known as MOONLIGHT-1.

Featured Image-  Megapixl @Vintikalexandr

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