ALPMY - Astellas reports 1-year safety data of fezolinetant to treat menopause symptoms

Astellas Pharma ( OTCPK:ALPMF ) ( OTCPK:ALPMY ) reported data from a phase 3 trial of its oral medicine fezolinetant to treat moderate to severe vasomotor symptoms (VMS) associated with menopause in women in mainland China.

The company said the main goal of the 52-week study, dubbed MOONLIGHT 3, is the frequency and severity of adverse events (AEs), which were generally consistent with previous phase 3 studies of fezolinetant.

VMS commonly called hot flashes or flushes, and night sweats are common symptoms of menopause.

The trial evaluated fezolinetant 30 mg taken once daily in 150 women.

"The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant," said Ahsan Arozullah, senior vice president and head of Development Therapeutic Areas, Astellas.

Astellas said the this result will have no impact on the financial forecasts of the current fiscal year ending March 31, 2023.

The company noted that in the U.S., a new drug application for fezolinetant to treat moderate to severe VMS associated with menopause is under review.

Fezolinetant had met the main goal of phase 3 trial, dubbed SKYLIGHT 4 , but had failed another phase 3 study called MOONLIGHT-1 .

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