Fervent Pharmaceuticals has initiated a Phase IIa clinical trial to investigate the therapeutic potential of FP-101 in treating vasomotor symptoms, including hot flashes, night sweats and insomnia, in post-menopausal women.
The two-month trial will enrol 112 patients from 12 participating clinical sites in the US states of Tennessee, North Carolina, and South Carolina.
Under the trial, the subjects will receive either FP-101 or placebo for eight weeks.
A patient diary will be maintained to record the frequency and duration of the patient’s vasomotor symptoms during the trial. The participating clinical sites will also carry out the relevant lab work of the patients.
Following screenings to be conducted by physicians, all patients will be provided with medical consultations during and after the trial.
Fervent Pharmaceuticals 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.
“We believe that this clinical trial will ultimately result in women everywhere having access to a menopausal treatment that's quite effective and, most importantly, safe.”
FP-101 is an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound. It has previously received approval from the US Food and Drug Administration (FDA) for use in an undisclosed indication.
In various preliminary studies, the drug has shown its potential for use in the treatment of vasomotor symptoms.
According to Fervent, the existing FDA-approved treatments of symptoms in post-menopausal women include oestrogen hormone replacement therapy, which poses an increased risk of heart disease, breast cancer, deep vein thrombosis, stroke and gall bladder disease.