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New Therapy for Treating Hot Flashes and Night Sweats

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Fervent Pharmaceuticals announced today that it has commenced its virtual clinical study to evaluate the effectiveness of its novel product for the treatment of the symptoms of moderate to severe hot flashes, night sweats and nighttime awakenings due to hot flashes. This product is intended to be available, if approved by the FDA, for patients without the need for a prescription. This type of remote study is one of the first of its kind authorized by the FDA. Patients in the study will participate remotely from the comfort of their own homes, where all investigational products will be delivered, and from where all data collection will occur.      

The M2S Hot Flash Study is designed to include peri-menopausal and post-menopausal women over the age of 45 who experience at least 7 to 8 moderate to severe hot flashes per day. Women who meet these criteria can apply at www.m2shotflashstudy.com to be considered for participation in this investigational study.

“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,” George Royster, Founder/CEO of Fervent Pharmaceuticals, said. “We are very excited to get this study underway and improve women’s lives through new therapies for menopausal symptoms.”

The three-week trial is being made available to eligible participants nationwide. Participants will be asked to track their vasomotor symptoms online during the trial and complete a survey at the conclusion of the study. The investigational products to be provided include an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, is already widely used for a different indication, and has a long history of safe use. The trial materials will also include training materials to educate participants on how to use the study’s patient reporting software.

Fervent Pharmaceuticals is a clinical stage drug development company founded in North Carolina in 2011. It is focused on improving women’s quality of life by developing therapies targeting unmet needs in women’s health.

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Editor in chief for eTurboNew is Linda Hohnholz. She is based in the eTN HQ in Honolulu, Hawaii.

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