Fervent Pharmaceuticals has announced the launch of clinical trials for their promising new post-menopausal drug therapy, FP-101. This two-month Phase 2a clinical trial, which involves 112 patients from across the Southeast, will assess the therapeutic potential of FP-101 in treating vasomotor symptoms, such as hot flashes, night sweats, and insomnia, in post-menopausal women.
FP-101 is an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, and is already FDA-approved for another undisclosed indication. In preliminary studies, Fervent’s FP-101 was shown to be potentially effective in treating vasomotor symptoms.
“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,” says George Royster, founder, president and chief executive officer of Fervent, in a release. “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.”
Participants in the clinical trial will take FP-101 or a placebo for 8 weeks. They will keep a patient diary of the frequency and duration of their vasomotor symptoms during this time, as well as have lab work done at their designated clinical site. All participants will have been screened by physicians and will be provided with medical consultations throughout and following the trial. There are 12 participating clinical sites in states including Tennessee, North Carolina, and South Carolina.
“We’re confident that the patients in this trial will be astonished at just how effective FP-101 is at treating their vasomotor symptoms,” Royster says “We are extremely excited about the hope that this product offers women suffering from hot flashes, night sweats, and insomnia. If the results we saw in preliminary studies are replicated in the trial, FP-101 is going to have a tremendous effect on the lives of menopausal women everywhere.”
When asked about the next steps following the much-anticipated successful outcome from the clinical trial, Royster says, “Fervent will be considering various options to sell or either out-license the asset to a very capable partner.”
Fervent Pharmaceuticals is a clinical-stage drug development company founded in North Carolina in 2011.