FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms

Inclusion Criteria: * Peri- and Post-Menopausal female subjects (\>45 yrs) experiencing a min of 7-8 moderate to severe hot flashes per day * Able/willing to provide informed consent. * Able/willing to complete all study procedures and visits. * Able/willing to not use any over-the-counter (OTC) cough \& cold medications that contain the IMP active during the study. Exclusion Criteria: * Subject exhibits positive home pregnancy test at screening or any time during study * Subject currently taking any form of Hormone Therapy (HT), including local estrogen therapies * Subject currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy. * Subject with history of serotonergic syndrome * Subject is currently taking monoamine oxidase inhibitors (MAOIs) (or for 2 weeks after stopping the MAOI drug), antidepressants, thioridazine, pimozide, cannabidiol, opioids, antipsychotic agents, antiretroviral agents, quinidine, quinine, or other medications for VMS such as Brisdelle® (paroxetine mesylate), clonidine and gabapentin. * Subject is currently taking a dietary/herbal supplement(s) to manage VMS, such as soy isoflavones or black cohosh. * Subject has uncontrolled diabetes, a history of hypertension \& is not on a stable dose of antihypertensive medications for at least 30 days prior to screening. * Subject has clinically unstable cardiac disease, including atrial fibrillation, symptomatic brady- or tachy-arrhythmias, congestive hea…