RCT Comparing Efficacy of FP-101 60mg b.i.d. vs. Placebo in Treatment of Moderate/Severe Hot Flashes in Menopausal Women

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release d-3-methoxy-N-methyl-morphinan hydrobromide oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fervent Pharmaceuticals
• Collaborator: ICON plc

Criteria

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 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 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 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 heart failure (NYHA class II, III, and IV), or symptomatic atherosclerotic cardiovascular disease (coronary artery disease, carotid artery disease or peripheral artery disease) or history of myocardial infarction or stroke within 2 years of enrolment in the study.

• Subject reports medical history suggestive of impaired liver/kidney function or, in the PI's opinion, exhibits liver/kidney function impairment to the extent that the subject should not participate in the study.

• Subject has biliary tract disease, adrenal cortical insufficiency, or any other medical condition that, in the PI's opinion (and after discussion with the medical monitor), is considered inadequately treated and precludes entry into the study.

• Subject has thyroid disease, unless subject is clinically stable with normal thyroid indices and is on maintenance thyroid medication (e.g., levothyroxine or liothyronine) for ≥6 months prior to screening.

• Subject has a history of, or is currently presenting with, substance use disorder as defined by the 5th Edition of the DSM. Subject has a history of psychiatric disorders, including a lifetime history of major depressive disorder, bipolar disorder, panic disorder, generalized anxiety, psychotic disorders, suicidality or suicidal ideation, or post-traumatic stress disorder.

• Subject is currently participating in another clinical trial

• Subjects who were determined to be placebo responders or non-compliant during the 1-week run-in period.