Fervent Pharmaceuticals of Greenville has finished a Phase 2A clinical trial of FP-101, its new therapy for treating symptoms of menopause including hot flashes and night sweats.
“Completing this clinical trial brings us one step closer to achieving our mission, which is to better women’s lives through new therapies for menopausal symptoms,” said George Royster, the company’s founder, president and chief executive officer. “Night sweats and hot flashes interrupt the everyday lives of women, and we’re addressing those symptoms through FP-101.”
FP-101 demonstrated a 90 percent efficacy rate in an earlier pilot study, and Fervent said it expected similar results to emerge from the clinical trial when the data have been fully analyzed.
The two-month clinical trial included 112 women in North Carolina, South Carolina, Illinois and Tennessee. Fervent partnered with PMG Research, a Winston-Salem contract research organization, to recruit patients and conduct the trial.
Long history of safe use
FP-101 is an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, is already FDA-approved for another undisclosed indication, and has a long history of safe use, the company said.
Fervent is able to use the Food and Drug Administration’s simpler application process for a new indication rather than the full application for a new compound. This expedited process, which uses prior research on the compound, will shorten the application time and lower the costs associated with bringing FP-101 to market, the company said.
Menopause marks the end of a woman’s reproductive capacity as she ages and stops releasing eggs each month through menstruation. Unwanted symptoms caused by hormonal changes can start occurring before or after menopause and last for several years.
Symptoms include the sudden sensations of intense heat, palpitations, irritability, skin reddening, and perspiration. They can cause sleep deprivation and interfere with work and lifestyle.
Most FDA-approved treatments of symptoms in post-menopausal women involve estrogen hormone replacement therapy, which carries an increased risk of heart disease, breast cancer, deep vein thrombosis, stroke and gall bladder disease.
Development of safe and effective new therapies would fill a significant unmet medical need. The U.S. market for a therapy includes 32 million women, and the global market encompasses 115 million women.
Fervent is a clinical stage drug-development company founded in 2011.
