US-based Fervent Pharmaceuticals is set to start a Phase lla clinical trial to evaluate the therapeutic potential of FP-101 in post-menopausal women.
The trial is expected to begin in the first quarter of this year and will enrol 110 women at a number of sites across the US.
Fervent has already submitted an investigational new drug (IND) application to the US Food and Drug Administration for using FP-101 in the treatment of menopause symptoms, especially hot flashes.
Fervent founder, president and CEO George Royster said: “We believe FP-101 has the potential to bring relief to millions of women suffering from hot flashes, night sweats and insomnia associated with menopause.
“Achievement of this regulatory milestone and the beginning of our clinical trial represents an important advancement in the development of FP-101.”
The FP-101 is an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation compound and is already been approved by FDA for another undisclosed indication.
The drug’s potential to treat the symptoms of menopause was discovered through what the company described as ‘serendipity and a keen eye for detail and observation’.
According to Fervent, most of the existing FDA-approved treatments for symptoms in post-menopausal women include estrogen hormone replacement therapy, which carries an increased risk of heart disease, breast cancer, deep vein thrombosis, stroke and gall bladder disease.
Formed in 2011, Fervent is primarily involved in developing therapies targeting unmet medical needs in women’s health.