Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brisdelle · 1 trial · 1 indication
The number of hot flashes reported in the result table are: * Mean change in frequency of moderate to severe VMS from baseline to Week 4 * Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week.
A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity. SS = (2•Fm + 3•Fs) ÷ (Fm + Fs) Where: SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score.
| Arm | Type | Description |
|---|---|---|
| Brisdelle (paroxetine mesylate) | EXPERIMENTAL | Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. |
| Placebo - Sugar Pill | PLACEBO_COMPARATOR | Eligible subjects will be randomized to receive a sugar pill. |
| Name | Type | Description |
|---|---|---|
| Brisdelle (paroxetine mesylate) | DRUG | Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg. |
| Sugar pill | DRUG | Subjects will receive a sugar pill. |
Inclusion Criteria: 1. Female, \>40 years of age 2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior 3. Spontaneous amenorrhea for at least 12 consecutive months 4. Amenorrhea for at least 6 months an...
Brisdelle is used for the treatment of hot flashes, also known as vasomotor symptoms, associated with menopause. It is being developed as a small molecule therapy for this condition, which falls under the endocrine therapeutic area.
Brisdelle is being developed by cbdMD, Inc., a company traded on the stock market under the ticker symbol YCBD. The company is advancing this drug through clinical development for the treatment of hot flashes.
Brisdelle is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its efficacy and safety in treating hot flashes associated with menopause.
Brisdelle has one completed clinical trial, identified as NCT00786188. This Phase 2 study was an eight-week efficacy and safety trial in the treatment of vasomotor symptoms associated with menopause. The trial enrolled 102 female participants in the United States.
Yes, Brisdelle was formerly known as Mesafem. The clinical trial NCT00786188 refers to the drug as Brisdelle, formerly known as Mesafem, indicating that these names refer to the same investigational drug for treating hot flashes.