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desvenlafaxine

Phase 4FDA approved 2013

Depression | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: Jan 2, 2012

desvenlafaxine development status

FDA approval Oct 11, 2013
Approval holderTeva Pharms Usa
ApplicationNDA205208
Highest phase Phase 4 run by Unity Health Toronto (NCT02859103)
Phase scored for PFEPhase 3
Registered trials 14 across 4 sponsors since Jun 2003

desvenlafaxine target and mechanism

Molecular targetSLC6A2, SLC6A4
Target classInhibitor
ModalitySmall molecule

Also known as desvenlafaxine succinate SR, Desvenlafaxine Succinate, desvenlafaxine succinate (DVS) SR, desvenlafaxine SR, DVS-233 SR

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials6
Total Enrollment4,145

FDA Designations

No designations recorded

desvenlafaxine clinical trials

desvenlafaxine · 6 trials · 5 indications

Phase 3 5Phase 1 1
NCT00683800Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal WomenVasomotor Symptoms
COMPLETED2,186 Analytics
NCT00366652Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy SubjectsDepression
COMPLETED20 Analytics
NCT00329147Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy SubjectsDepression
COMPLETED20 Analytics
NCT00300378Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive DisorderDepressive Disorder, Major
COMPLETED480 Analytics
NCT01309542Long-Term Safety Of DVS-233 SR In Patients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED1,403 Analytics
PHASE3COMPLETED
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
Vasomotor SymptomsUnlock trial analytics
PHASE3COMPLETED
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
DepressionUnlock trial analytics
PHASE3COMPLETED
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
DepressionUnlock trial analytics
PHASE3COMPLETED
Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder
Depressive Disorder, MajorUnlock trial analytics
PHASE3COMPLETED
Long-Term Safety Of DVS-233 SR In Patients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4
Baseline and Week 4

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.

Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12
Baseline and Week 12

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.

Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4
Baseline and Week 4

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.

Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12
Baseline and Week 12

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.

Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events
Baseline up to Month 12

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.

The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
Number (%) of Subjects Reporting Adverse Events during Treatment
10 months
Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
10 months
Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
10 months
Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance
10 months
For single dose: maximum concentration (Cmax)
day 1
For single dose: time to first occurence of Cmax (Tmax)
day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)
day 1
For multiple dose: maximum concentration (Cmax)
day 8
For multiple dose: time to first occurence of Cmax (Tmax)
day 8
For multiple dose: trough concentration (Ctrough)
day 8
For multiple dose: area under curve (0-24hours) (AUC0-24)
day 8

Secondary Endpoints

Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes
Baseline and Week 12
Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
Baseline, Week 4 and Week 12
Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes
Baseline, Week 4 and Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALdesvenlafaxine succinate (DVS) SR
2PLACEBO_COMPARATORPlacebo
DVSEXPERIMENTAL -
50 mgEXPERIMENTAL -
100 mgEXPERIMENTAL -
200 mgEXPERIMENTAL -

Interventions

NameTypeDescription
desvenlafaxine succinate (DVS) SRDRUGTitration 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.
PlaceboDRUGTitration 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 SRDRUG -
desipramineDRUG -
duloxetineDRUG -
paroxetineDRUG -
desvenlafaxine 50 mgDRUG -
desvenlafaxine 100 mgDRUG -
Desvenlafaxine SuccinateDRUGTablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
desvenlafaxineDRUGone 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
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Eligibility Criteria

Age Range45 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites121

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...

Countries:United StatesCanadaCroatiaEstoniaFinlandFranceLatviaLithuaniaPolandRomaniaSlovakiaSouth AfricaGermanySerbia and MontenegroSouth Korea
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Frequently asked questions about desvenlafaxine

What is desvenlafaxine?

Desvenlafaxine is a small molecule drug developed by Pfizer, Inc. (ticker PFE) for depression, major depressive disorder, and vasomotor symptoms. It is also known as desvenlafaxine succinate SR, desvenlafaxine succinate, desvenlafaxine succinate (DVS) SR, desvenlafaxine SR, and desvenlafaxine 50 mg. It is in Phase 3 development.

What does desvenlafaxine target?

Desvenlafaxine targets SLC6A2 and SLC6A4. It is classified as an inhibitor. By inhibiting these targets, it affects serotonin and norepinephrine pathways, which are relevant to its studied uses in major depressive disorder and vasomotor symptoms.

Who makes desvenlafaxine?

Desvenlafaxine is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for desvenlafaxine succinate sustained release across the studied indications.

What phase is desvenlafaxine in?

Desvenlafaxine is in Phase 3 development. It is investigational and has been studied in completed Phase 3 trials for major depressive disorder and vasomotor symptoms, as well as earlier pharmacokinetic studies. No approval status is stated in the available development information.

What clinical trials is desvenlafaxine in?

Desvenlafaxine has been studied in completed trials including NCT01309542, a Phase 3 long-term safety study in major depressive disorder with 1,403 patients, and NCT00683800, a Phase 3 study of vasomotor symptoms in menopausal women with 2,186 patients. Other completed trials include NCT01443208 and NCT00366652.

Is desvenlafaxine the same as desvenlafaxine succinate SR?

Yes. Desvenlafaxine is also known as desvenlafaxine succinate SR, desvenlafaxine succinate, desvenlafaxine succinate (DVS) SR, desvenlafaxine SR, and desvenlafaxine 50 mg. These names refer to the same small molecule drug developed by Pfizer for depression, major depressive disorder, and vasomotor symptoms.