Fervent Pharmaceuticals has initiated a virtual at home Phase II clinical trial of its new product to treat the symptoms of moderate to severe hot flashes, night sweats and night-time awakenings due to hot flashes in women.

Named M2S Hot Flash Study, the trial will analyse the peri- and post-menopausal therapy to treat hot flashes and night sweats.

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This is the one of the first of its kind remote trial to obtain authorisation from the FDA, the company noted.

The three-week trial will enrol include peri-menopausal and post-menopausal women aged over 45 years who experience a minimum of seven to eight moderate to severe hot flashes a day.

Trial participants can take part remotely in the comfort of their homes while the investigational therapies will be supplied to them, and data will be collected.

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During the trial, the subjects will track their vasomotor symptoms online and complete a survey following the trial conclusion.

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An investigational drug, FP-101 is being developed to treat vasomotor symptoms or VMS as an extended-release oral tablet. 

It is a non-hormonal, non-herbal, non-antidepressant formulation of a compound with established mechanisms of action with a long history of safe usage.

On obtaining approval from the FDA, this therapy will be made available for patients without requiring a prescription.

Fervent Pharmaceuticals Founder and CEO George Royster said: “I am excited about the product we are investigating and the possibilities it may hold for the improvement in these patients’ quality of life. 

“Further, having a study design that brings the convenience of participation directly into the patients’ homes allows more patients to potentially participate, and do so on their schedules.”