Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
desvenlafaxine sustained release · 6 trials · 5 indications
HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.
Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom", "absent", or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Cmax measured as nanograms divided by milliliters (ng/mL).
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| C | ACTIVE_COMPARATOR | - |
| D | ACTIVE_COMPARATOR | - |
| E | ACTIVE_COMPARATOR | - |
| F | ACTIVE_COMPARATOR | - |
| G | ACTIVE_COMPARATOR | - |
| H | PLACEBO_COMPARATOR | - |
| Bioequivalence and Food effect | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| desvenlafaxine succinate sustained release | DRUG | 50 mg/day oral tablet for 12 weeks |
| Genotyping | GENETIC | CYP2D6 genotyping at randomization |
| Placebo | DRUG | Tapering placebo |
| Desvenlafaxine Sustained Release | DRUG | - |
| Desvenlafaxine Sustained Release (DVS SR) | DRUG | - |
| Paroxetine | DRUG | - |
| Codeine | DRUG | - |
Inclusion Criteria: * Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English. * Employed for 20 hours or more for a minimum of 1 month prior to baseline. * Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to bas...
Desvenlafaxine Sustained Release is an investigational small molecule being studied for major depressive disorder, vasomotor symptoms, and fibromyalgia. It is developed by Pfizer, Inc. (PFE). The drug is in Phase 2 clinical development and is not approved by the FDA.
Desvenlafaxine Sustained Release is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being studied for its effects on depression, vasomotor symptoms, and fibromyalgia, though the mechanism of action is not detailed.
Desvenlafaxine Sustained Release is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The drug is currently in Phase 2 clinical development for major depressive disorder, vasomotor symptoms, and fibromyalgia.
Desvenlafaxine Sustained Release is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The development program includes completed Phase 1, Phase 2, and Phase 3 trials across various indications, but the current stage is Phase 2.
Desvenlafaxine Sustained Release has completed five clinical trials, including NCT00424892 in fibromyalgia, NCT00863798 in major depressive disorder, NCT01190514 a bioequivalence study, and NCT01371734 in children and adolescents with major depressive disorder. All trials are completed, with no active trials ongoing.
Desvenlafaxine Sustained Release is also known as desvenlafaxine succinate sustained release, often abbreviated as DVS SR. Clinical trials such as NCT01190514 refer to the drug as desvenlafaxine succinate sustained release, confirming that these names describe the same investigational compound.