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