CLINICAL TRIALS PROFILE FOR EFFEXOR XR

505(b)(2) Clinical Trials for Effexor Xr

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT05875610 ↗	Preventive Approach Using Venlafaxine	Recruiting	Mit Ghamr Oncology Center	Phase 4	2023-05-01	Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.

All Clinical Trials for Effexor Xr

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001483 ↗	Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-06-01	This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
NCT00043550 ↗	Treatments for Depression: Drug Versus Psychotherapy	Completed	National Institute of Mental Health (NIMH)	Phase 3	2001-11-01	This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
NCT00043550 ↗	Treatments for Depression: Drug Versus Psychotherapy	Completed	University of Pennsylvania	Phase 3	2001-11-01	This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
NCT00045916 ↗	Optimizing Electroconvulsive Therapy for Depression	Completed	National Institute of Mental Health (NIMH)	Phase 4	2001-02-01	This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.
NCT00045916 ↗	Optimizing Electroconvulsive Therapy for Depression	Completed	New York State Psychiatric Institute	Phase 4	2001-02-01	This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.
NCT00046020 ↗	Study Evaluating Venlafaxine ER in Recurrent Depression	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 4	2000-08-01	The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression

Clinical Trial Conditions for Effexor Xr

Condition Name

Condition Name for Effexor Xr
Intervention	Trials
Depression	15
Healthy	12
Major Depressive Disorder	10
Depressive Disorder, Major	4

Condition MeSH

Condition MeSH for Effexor Xr
Intervention	Trials
Depression	33
Depressive Disorder	28
Depressive Disorder, Major	15
Disease	11

Clinical Trial Locations for Effexor Xr

Trials by Country

Trials by Country for Effexor Xr
Location	Trials
United States	115
Japan	47
China	12
Canada	12
United Kingdom	3

Trials by US State

Trials by US State for Effexor Xr
Location	Trials
New York	10
Florida	8
California	6
North Carolina	6
Missouri	6

Clinical Trial Progress for Effexor Xr

Clinical Trial Phase

Clinical Trial Phase for Effexor Xr
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	9
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Effexor Xr
Clinical Trial Phase	Trials
Completed	48
Unknown status	4
Withdrawn	4

Clinical Trial Sponsors for Effexor Xr

Sponsor Name

Sponsor Name for Effexor Xr
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	7
Teva Pharmaceuticals USA	5
National Institute of Mental Health (NIMH)	5

Sponsor Type

Sponsor Type for Effexor Xr
Sponsor	Trials
Other	52
Industry	32
NIH	10

Effexor XR: Clinical Trials, Market Analysis, and Projections

Introduction

Effexor XR, the extended-release formulation of venlafaxine hydrochloride, is a widely used medication for treating various mental health conditions, including major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder. This article delves into the clinical trials that have established its efficacy, the current market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Major Depressive Disorder

Clinical trials have consistently shown the efficacy of Effexor XR in treating major depressive disorder. Two placebo-controlled, short-term studies demonstrated that patients receiving Effexor XR experienced significant improvements in depressive symptoms compared to those on a placebo. The mean dose in these studies ranged from 75 to 150 mg/day, with a mean dose for completers of 136 mg/day[1][4].

Generalized Anxiety Disorder (GAD)

Effexor XR has been proven effective in treating GAD through several clinical trials. Studies using the Hamilton Anxiety Rating Scale (HAM-A) showed that patients taking Effexor XR had significantly lower HAM-A scores compared to those on a placebo, indicating improved symptoms of GAD. The doses of Effexor XR in these trials ranged from 75 to 225 mg/day[1][4].

Social Anxiety Disorder

The efficacy of Effexor XR in treating social anxiety disorder has been established through double-blind, placebo-controlled studies. These studies used the Liebowitz Social Anxiety Scale (LSAS) and showed that Effexor XR significantly reduced LSAS scores, indicating improved symptoms of social anxiety disorder. Doses ranged from 75 to 225 mg/day[1][4].

Panic Disorder

Clinical trials have also demonstrated the effectiveness of Effexor XR in treating panic disorder. Studies assessed outcomes using the Panic and Anticipatory Anxiety Scale (PAAS) and the Panic Disorder Severity Scale (PDSS), showing that Effexor XR was significantly more effective than a placebo in reducing panic attacks and improving overall symptoms[1].

Market Analysis

Global Market Trends

The global venlafaxine market, which includes Effexor XR, is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2022 to 2029. This growth is driven by several factors, including the increasing prevalence of anxiety and social anxiety disorders, a rising geriatric population, and increased healthcare expenditure[2].

Market Share and Distribution

In China, despite entering the market later than other regions, Effexor XR holds a significant market share. In 2020, it accounted for about 50% of the market share in terms of sales value. The Chinese venlafaxine market experienced a decline in 2020 due to the COVID-19 pandemic but is expected to see growth from 2021 to 2025 as the pandemic is brought under control[5].

Distribution Channels

The venlafaxine market, including Effexor XR, is distributed through various channels such as hospital pharmacies, retail pharmacies, and online pharmacies. This diverse distribution network helps in making the medication more accessible to patients worldwide[2].

Projections and Future Outlook

Market Growth Drivers

The venlafaxine market is expected to be driven by several factors, including:

• Increasing Prevalence of Mental Health Disorders: The rising prevalence of anxiety, social anxiety, and depressive disorders will continue to drive the demand for effective treatments like Effexor XR.
• Government Initiatives and Awareness: Growing government initiatives and public awareness campaigns about mental health are expected to increase the adoption of venlafaxine-based treatments.
• Research and Development: Ongoing research and development activities, including strategic collaborations, will provide new opportunities for the venlafaxine market[2].

Challenges

Despite the positive outlook, the market faces several challenges:

• High Cost and Side Effects: The high cost of the drug and associated side effects, such as loss of appetite, diarrhea, headache, nausea, and dizziness, can hamper market growth.
• Lack of Awareness: In some regions, a lack of awareness about mental health conditions and available treatments can limit the market expansion[2].

Financial Sponsorship and Clinical Trial Efficacy

Impact of Financial Sponsorship

Studies have shown that financial sponsorship of clinical trials can influence the reported efficacy of drugs. For instance, trials funded solely by Wyeth found Effexor to be more effective than Prozac in most cases, whereas trials with alternate funding showed less consistent results. This highlights the importance of considering the funding source when evaluating clinical trial outcomes[3].

Side Effects and Safety Considerations

Common Side Effects

Effexor XR is associated with several common side effects, including loss of appetite, diarrhea, headache, nausea, and dizziness. In children, it has been observed to slow growth in height, particularly in those under the age of 12[4].

Dosage and Administration

The dosage of Effexor XR varies depending on the condition being treated and the patient's response. It is available in extended-release capsules, and dosage adjustments may be necessary for patients with certain medical conditions or those taking other medications[1].

Key Takeaways

• Efficacy in Mental Health Conditions: Effexor XR has been proven effective in treating major depressive disorder, GAD, social anxiety disorder, and panic disorder through multiple clinical trials.
• Market Growth: The global venlafaxine market is expected to grow at a CAGR of 4% from 2022 to 2029, driven by increasing prevalence of mental health disorders and other factors.
• Challenges: High cost, side effects, and lack of awareness are significant challenges facing the market.
• Financial Sponsorship Impact: Financial sponsorship of clinical trials can influence reported drug efficacy, emphasizing the need for diverse funding sources.

FAQs

Q: What conditions is Effexor XR used to treat?

Effexor XR is used to treat major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder.

Q: What are the common side effects of Effexor XR?

Common side effects include loss of appetite, diarrhea, headache, nausea, and dizziness. In children, it can slow growth in height.

Q: How does the dosage of Effexor XR vary?

The dosage varies depending on the condition being treated and the patient's response. It is available in extended-release capsules, and dosage adjustments may be necessary for certain patients.

Q: What drives the growth of the venlafaxine market?

The market growth is driven by the increasing prevalence of anxiety and social anxiety disorders, a rising geriatric population, and increased healthcare expenditure.

Q: What challenges does the venlafaxine market face?

The market faces challenges such as high drug costs, associated side effects, and a lack of awareness about mental health conditions and available treatments.

Sources

1. Effexor XR - accessdata.fda.gov
2. Global Venlafaxine Market - Data Bridge Market Research
3. Funding of Clinical Trials and Reported Drug Efficacy - GitHub Pages
4. Effexor XR (venlafaxine): Side effects, dosage, uses, and more - Medical News Today
5. Research Report On China's Venlafaxine Market, 2021-2025 - CRI Report