Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
desvenlafaxine · 8 trials · 6 indications
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\*Number of mild+2\*Number of moderate+3\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1\*Number of mild+2\*Number of moderate+3\*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.
Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | desvenlafaxine succinate (DVS) SR |
| 2 | PLACEBO_COMPARATOR | Placebo |
| DVS | EXPERIMENTAL | - |
| 50 mg | EXPERIMENTAL | - |
| 100 mg | EXPERIMENTAL | - |
| 200 mg | EXPERIMENTAL | - |
| desvenlafaxine succinate SR | EXPERIMENTAL | desvenlafaxine succinate SR |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| desvenlafaxine succinate (DVS) SR | DRUG | Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days. |
| Placebo | DRUG | Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days. |
| desvenlafaxine SR | DRUG | - |
| desipramine | DRUG | - |
| duloxetine | DRUG | - |
| paroxetine | DRUG | - |
| venlafaxine ER | DRUG | - |
| desvenlafaxine 50 mg | DRUG | - |
| desvenlafaxine 100 mg | DRUG | - |
| Desvenlafaxine Succinate | DRUG | Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months |
| desvenlafaxine | DRUG | one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days |
| desvenlafaxine succinate SR | DRUG | desvenlafaxine succinate SR |
Inclusion Criteria: * Generally healthy, postmenopausal women who seek treatment for hot flushes * Body Mass Index (BMI) less than or equal to 34 kg/m\^2 Exclusion Criteria: * Hypersensitivity to Venlafaxine * Myocardial infarction an/or unstable angina within 6 months of screening * History of s...
Desvenlafaxine is an investigational small molecule being developed for psychiatric conditions including major depressive disorder, depression, and vasomotor symptoms. It is currently in Phase 3 clinical development and is not yet approved by the FDA.
Desvenlafaxine is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Desvenlafaxine is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The Phase 3 trials are completed, and the drug is being studied for major depressive disorder and related conditions.
Desvenlafaxine has completed several clinical trials, including NCT00329147, NCT00329186, NCT00366652, and NCT00818155. These trials evaluated the drug's pharmacokinetics and safety in healthy subjects and patients with depression, with a total enrollment of 2186 participants.
Desvenlafaxine is a distinct drug from venlafaxine. One completed trial, NCT00329186, directly compared the pharmacokinetics of venlafaxine ER and desvenlafaxine SR in healthy subjects, indicating they are separate compounds with different properties.