GREENVILLE, N.C., March 14, 2019 — Fervent Pharmaceuticals is pleased to announce positive proof of concept results from its Phase IIA clinical trial of FP-101, a non-hormonal, non-herbal, non-antidepressant treatment of the vasomotor symptoms that accompany menopause.
The 8-week, 112 patient, placebo-controlled study focused on the treatment of hot flashes and night sweats in menopausal women. The study demonstrated that the patients experienced a reduction in their hot flashes and night sweats versus placebo.
The trial included a small six patient sub-study of breast cancer survivors undergoing Tamoxifen treatment. Breast cancer survivors are often prescribed Tamoxifen, but the drug can cause the side effect of inducing hot flashes and night sweats. The trial showed that FP-101 helped minimize these side effects in the sub-study’s participants. This is encouraging news for breast cancer survivors taking Tamoxifen, who often cannot take current treatment options like Hormone Replacement Therapy or antidepressants due to cancer risk or drug-drug interactions.
“We’re pleased to receive these results, which help us move even closer to providing a safe and effective solution for women that suffer from hot flashes and night sweats during menopause,” said George Royster, founder and CEO of Fervent Pharmaceuticals. “We are also pleased that FP-101 demonstrates the potential to bring relief to breast cancer survivors coping with hot flashes and night sweats caused by their ongoing cancer treatments”.
FP-101 is a repurposed drug. Its active ingredient has a long history of safe use.
“We anticipate FP-101 will be an important option for women’s healthcare,” said Dr. Ernest Mario, a Fervent Board member. “These early results are quite encouraging.”
Fervent Pharmaceuticals, LLC, is a clinical-stage drug development company founded in 2011. It is focused on developing therapies targeting unmet medical needs in women’s health, including vasomotor symptoms of menopause like hot flashes, night sweats, and insomnia.
For more information about Fervent, visit the company’s website at www.ferventpharma.com.
SOURCE Fervent Pharmaceuticals