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DVS-233

Phase 3

Depression | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: Aug 19, 2009

DVS-233 development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Sep 2005

DVS-233 target and mechanism

ModalitySmall molecule

Also known as DVS-233 SR, DVS-233 SR (desvenlafaxine sustained release )

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials11
Total Enrollment4,260

FDA Designations

No designations recorded

DVS-233 clinical trials

DVS-233 · 11 trials · 7 indications

Phase 3 11
NCT00195546Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With MenopauseMenopause
COMPLETED465 Analytics
NCT00256685Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With MenopauseMenopause
COMPLETED568 Analytics
NCT00452595Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED- Analytics
NCT00421031Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With MenopauseVasomotor Symptoms
COMPLETED540 Analytics
NCT00063206Study Evaluating DVS-233 in Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED247 Analytics
NCT00072774Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED480 Analytics
NCT00073762Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED375 Analytics
NCT00075257Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED603 Analytics
NCT00087737Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED369 Analytics
NCT00090649Study Evaluating DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED369 Analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
MenopauseUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
MenopauseUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
Vasomotor SymptomsUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE3COMPLETED
Study Evaluating DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone.
Reduction in average daily number of moderate & severe hot flushes and average daily severity score at weeks 4 & 12
HAM-D17
The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause.

Secondary Endpoints

To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
Sleep, mood
MADRS, CGI-S, CGI-I, Covi Anxiety Scale, SDS, VAS-PI, and WHO-5
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
DVS-233DRUG -
DVS-233 SRDRUG -
DVS-233 SR (desvenlafaxine sustained release )DRUG -
Venlafaxine ERDRUG -
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Eligibility Criteria

Age Range40 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last natural menstrual period (LNMP) completed at least 12 months prior to screening. * Minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7 consecutive days * Body Mass In...

Countries:BelgiumCroatiaCzechiaFinlandFranceHungaryMexicoNetherlandsPolandRomaniaSouth AfricaSpainSwedenUkraineUnited KingdomUnited States
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Frequently asked questions about DVS-233

What is DVS-233?

DVS-233 is an investigational small molecule developed by Pfizer, Inc. (PFE) for major depressive disorder and vasomotor symptoms associated with menopause. It is also known as DVS-233 SR, or desvenlafaxine sustained release. It has been studied in Phase 3 clinical trials.

What is DVS-233 used for?

DVS-233 is being developed for the treatment of major depressive disorder and for vasomotor symptoms associated with menopause. It has been evaluated in Phase 3 trials for these conditions, including studies in outpatients with depression and in women experiencing menopausal hot flashes.

Who makes DVS-233?

DVS-233 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical trials evaluating DVS-233 for major depressive disorder and menopausal vasomotor symptoms.

What phase is DVS-233 in?

DVS-233 is in Phase 3 clinical development. Seven Phase 3 trials have been completed, and no active trials are currently listed. The completed studies enrolled a total of 2,443 participants and evaluated DVS-233 for major depressive disorder and menopausal vasomotor symptoms.

What clinical trials is DVS-233 in?

DVS-233 has been studied in completed Phase 3 trials including NCT00452595 in major depressive disorder, NCT00421031 and NCT00256685 in menopausal vasomotor symptoms, and NCT00195546 in menopause. These trials were randomized and double-blind, with some conducted across multiple countries.

Is DVS-233 the same as DVS-233 SR?

Yes, DVS-233 SR is an alternative name for DVS-233. It is also known as desvenlafaxine sustained release. The SR designation refers to the sustained-release formulation used in the clinical development program for major depressive disorder and menopausal vasomotor symptoms.