NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
5/8 — Partial
EFFEXOR XR (venlafaxine hydrochloride) by Viatris (2) is mdd, gad, sad, and pd is unclear, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. First approved in 1997.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EFFEXOR XR is an extended-release oral capsule formulation of venlafaxine hydrochloride approved in 1997 for treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder (PD). It works by inhibiting the reuptake of serotonin and norepinephrine in the central nervous system, increasing their availability at synaptic sites. The mechanism is characteristic of serotonin-norepinephrine reuptake inhibitors (SNRIs).
$0.026BPart D
LOE ApproachingProduct is in LOE-approaching stage with modest Part D spending of $26M annually, indicating a mature franchise with potential team restructuring ahead.
Mechanism of Action
MDD, GAD, SAD, and PD is unclear, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets
Started May 2024
736 enrolled
Major Depressive Disorder
A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
Started Jul 2023
555 enrolled
Generalized Anxiety Disorder
A Study to Assess The Effects Of Effexor XR On Cardiac Repolarization In Healthy Adult Subjects
Started Dec 2015
54 enrolled
Healthy Subjects
Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
Started Oct 2010
80 enrolled
Healthy
Study Evaluating Effexor XR in Chinese Subjects With Major Depressive Disorder
Started Apr 2009
0Major Depressive Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.