Fervent Pharmaceuticals to Initiate Clinical Trial of New Menopause Therapy.
M2 PHARMA-January 2, 2018-Fervent Pharmaceuticals to Initiate Clinical Trial of New Menopause Therapy
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- Greenville, North Carolina-based drug development company Fervent Pharmaceuticals has successfully submitted an investigational new drug application to the US Food and Drug Administration for FP-101, its proprietary lead drug candidate for treating menopause symptoms, especially hot flashes, the company said.
A Phase 2a clinical trial will now begin to assess the therapeutic potential of FP-101 in post-menopausal women. The trial will enroll 110 women at a dozen study sites in Illinois, North Carolina, South Carolina, and Tennessee.
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.
Fervent has received assistance from the North Carolina Biotechnology Center and its Eastern Regional Office, headed by Mark Phillips, vice president of statewide operations and executive director of the office.
The company is working with the University of Iowa Pharmaceuticals on drug formulation, and with IQVIA (formerly QuintilesIMS) of Durham and PMG Research of Winston-Salem for clinical trial design and execution.
Fervent, founded in 2011, is focused on developing therapies targeting unmet medical needs in women's health.
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|Date:||Jan 2, 2018|
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