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Desvenlafaxine administered as a salt in a sustained-release form

Phase 3

Depression | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: May 7, 2012

Desvenlafaxine administered as a salt in a sustained-release form target and mechanism

Molecular targetSLC6A2, SLC6A4
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment381

FDA Designations

No designations recorded

Desvenlafaxine administered as a salt in a sustained-release form clinical trials

Desvenlafaxine administered as a salt in a sustained-release form · 1 trial · 3 indications

Phase 3 1
NCT00369343Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal WomenDepression
COMPLETED381 Analytics
PHASE3COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
Baseline to 8 weeks

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17

Secondary Endpoints

Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
8 weeks
Percentage of Patients Achieving Remission
8 weeks
Percentage of Patients Achieving Response to Treatment
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)DRUGDVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
PlaceboDRUGPlacebo, daily (QD), tablet form, treatment period up to 8 weeks
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Eligibility Criteria

Age Range40 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive. * A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI). * Montgomery-Asberg Depression Rating Scale ...

Countries:United States
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Frequently asked questions about Desvenlafaxine administered as a salt in a sustained-release form

What is desvenlafaxine administered as a salt in a sustained-release form?

Desvenlafaxine administered as a salt in a sustained-release form is an investigational small molecule being developed by Pfizer, Inc. (PFE) for depression. It is a sustained-release formulation of desvenlafaxine, the active metabolite of venlafaxine, and is also known as desvenlafaxine succinate sustained release (DVS SR).

What is desvenlafaxine administered as a salt in a sustained-release form used for?

Desvenlafaxine administered as a salt in a sustained-release form is being studied for the treatment of depression, including depressive disorder and major depressive disorder. Its clinical development has focused on peri- and postmenopausal women with depression, a population evaluated in its Phase 3 trial.

How does desvenlafaxine administered as a salt in a sustained-release form work?

Desvenlafaxine administered as a salt in a sustained-release form acts as an inhibitor of SLC6A2 (norepinephrine transporter) and SLC6A4 (serotonin transporter). By inhibiting these transporters, it increases norepinephrine and serotonin levels in the brain, which is the proposed mechanism for its antidepressant activity.

Who is developing desvenlafaxine administered as a salt in a sustained-release form?

Pfizer, Inc. (ticker: PFE) is the developer of desvenlafaxine administered as a salt in a sustained-release form. Pfizer conducted the Phase 3 clinical trial evaluating this sustained-release formulation in peri- and postmenopausal women with depression.

What phase is desvenlafaxine administered as a salt in a sustained-release form in?

Desvenlafaxine administered as a salt in a sustained-release form is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for any indication. The Phase 3 trial for this formulation has been completed.

What clinical trials is desvenlafaxine administered as a salt in a sustained-release form in?

Desvenlafaxine administered as a salt in a sustained-release form has been evaluated in one completed Phase 3 trial, NCT00369343, titled "Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women." The trial enrolled 381 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is desvenlafaxine administered as a salt in a sustained-release form the same as DVS SR?

Yes, desvenlafaxine administered as a salt in a sustained-release form is also known as desvenlafaxine administered as a succinate salt in a sustained-release form, abbreviated DVS SR. The two names refer to the same investigational product developed by Pfizer for depression.