For the treatment of moderate to severe Vasomotor Symptoms (VMS) in post-menopausal women, Astellas’ Fezolinetant, has shown efficacious and exceptional topline outcomes in both Phase III trials conducted to evaluate the drug.
To regulate the neuronal activity in the thermoregulatory center in the hypothalamus, Fezolinetant, a selective neurokinin-3 receptor (NK3R) antagonist, deter neurokinin B binding on the kisspeptin/neurokinin/dynorphin neuron.
Dubbed as SKYLIGHT 1 and SKYLIGHT 2, the two phase III trials are randomized, double-blind and placebo-controlled ongoing trails to assess the safety and efficacy of 30 mg and 45 mg Fezolinetant taken once a day on daily basis. The trials are being conducted on 1028 women of age between 40 and 65 having moderate to severe VMS.
The first 12 weeks were comprised of double-blinded and placebo-controlled trails with a subsequent extension period of 40 weeks of active treatment.
According to the obtained results, both doses of the drug, as compared to the placebo, met all 4 co-primary endpoints demonstrating significant reductions in severity and recurrence of the VMS at week 4 and week 12 respectively.
Fezolinetant’s most prevailing treatment emergent adverse event (TEAE) for patients was the headache which was found to be only 2% in its grim manifestation.
Salim Mujais, Managing Director, Senior Vice President and Therapeutic Area Head, Medical Specialties of Astellas Pharma Inc., said that the initial results from the phase III trials of Fezolinetant are encouraging for the company.