GREENVILLE, N.C., Nov. 14, 2018 /PRNewswire/ -- Fervent Pharmaceuticals of Greenville, N.C. has successfully completed its Phase 2A clinical trial for FP-101, a new therapy developed to treat the vasomotor symptoms associated with menopause, like hot flashes and night sweats.
The two-month clinical trial included 112 women in North Carolina, South Carolina, Illinois, and Tennessee. Fervent partnered with Winston-Salem-based PMG Research to recruit patients and conduct the trial.
"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," George Royster, founder of Fervent Pharmaceuticals, said. "Night sweats and hot flashes interrupt the everyday lives of women, and we're addressing those symptoms through FP-101."
The therapy in trial 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.
FP-101 demonstrated a 90% efficacy rate in its pilot study, and Fervent expects similar results to emerge from the clinical trial when the data has been fully analyzed.
Fervent is able to utilize the FDA'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 application time and lower the costs associated with bringing FP-101 to market.
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. Learn more at www.FerventPharma.com.
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The two-month clinical trial included 112 women in North Carolina, South Carolina, Illinois, and Tennessee. Fervent partnered with Winston-Salem-based PMG Research to recruit patients and conduct the trial.
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"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," George Royster, founder of Fervent Pharmaceuticals, said. "Night sweats and hot flashes interrupt the everyday lives of women, and we're addressing those symptoms through FP-101."
The therapy in trial 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.
FP-101 demonstrated a 90% efficacy rate in its pilot study, and Fervent expects similar results to emerge from the clinical trial when the data has been fully analyzed.
Fervent is able to utilize the FDA'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 application time and lower the costs associated with bringing FP-101 to market.
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. Learn more at www.FerventPharma.com.
View original content:http://www.prnewswire.com/news-releases/fervent-pharmaceuticals-completes-clinical-trial-for-promising-new-post-menopausal-therapy-treating-vasomotor-symptoms-300750520.html
SOURCE Fervent Pharmaceuticals
