CLINICAL TRIALS PROFILE FOR EFFEXOR

505(b)(2) Clinical Trials for Effexor

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

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.

Clinical Trial Conditions for Effexor

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Effexor

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Effexor

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	4

Clinical Trial Sponsors for Effexor

Sponsor Name

Sponsor Name for Effexor
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
Sponsor	Trials
Other	52
Industry	32
NIH	10

EFFEXOR (Venlafaxine): Clinical Trials Update, Market Analysis, and Projections

Clinical Trials Update

Phase 3 Study in Japan for Generalized Anxiety Disorder (GAD)

Viatris Inc. has recently announced positive top-line results from its Phase 3 study (B2411367) conducted in Japan to evaluate the safety and efficacy of EFFEXOR® (venlafaxine) in adults with generalized anxiety disorder (GAD)[1][2][4].

• Primary Objective: The study achieved its primary objective by demonstrating the superiority of venlafaxine over placebo in reducing anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline at 8 weeks.
• Secondary Objectives: All seven secondary efficacy endpoints were met, confirming the superiority of venlafaxine compared to placebo. These endpoints included the HAM-A psychic and somatic anxiety factors, Clinical Global Impressions-Severity of Illness (CGI-S) and Global Improvement (CGI-I), Generalized Anxiety Disorder 7 (GAD-7), Zung Self-Rating Anxiety Scale (ZSRAS), and Sheehan Disability Scale (SDISS)[1][2][4].

Safety and Tolerability

The study showed that EFFEXOR® was generally well tolerated, consistent with its known safety profile. Key findings include:

• Low discontinuation rates due to treatment-emergent adverse events (TEAEs) at 7.3% compared to 1.7% in the placebo group.
• No serious TEAEs or TEAEs with severe intensity were observed.
• The incidence of new suicidal ideation was lower in the EFFEXOR® treatment group than in the placebo group (2.8% vs 5.1%)[1][2][4].

Regulatory Submission

Viatris plans to submit the findings to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, targeting a submission in 2025. The company also expects to present the full results from this Phase 3 study at a future medical congress[1][2][4].

Market Analysis

Current Market Status

EFFEXOR® (venlafaxine) is currently approved in Japan for the treatment of major depressive disorder in adults but not for generalized anxiety disorder (GAD). However, it has been approved for GAD in over 80 countries outside of Japan[1][2][4].

Market Growth Drivers

The venlafaxine market is expected to grow driven by several factors:

• Increasing Prevalence of Anxiety Disorders: The rise in the prevalence of anxiety and social anxiety disorders is a significant driver for the expansion of the venlafaxine market[3].
• Growing Geriatric Population: An increasing geriatric population and rising healthcare expenditure are also contributing to market growth[3].
• Government Initiatives and Awareness: Growing government initiatives and rising awareness about mental health issues are positively impacting the market[3].

Market Projections

The global venlafaxine market is projected to grow at a CAGR of 4% from 2022 to 2029. This growth is attributed to the increasing demand for treatments of anxiety and depressive disorders, as well as the expanding geriatric population and rising healthcare expenditures[3].

Antidepressant Market Context

The broader antidepressant drugs market is also expected to see significant growth. By 2033, the market is projected to reach a revenue of USD 26.9 billion, growing at a CAGR of 3.3% from 2025[5].

Challenges and Limitations

Side Effects and Cost

Despite the positive outlook, the venlafaxine market faces challenges such as high drug costs and side effects associated with venlafaxine, including loss of appetite, diarrhea, headache, nausea, dizziness, and seizures. These factors can hamper market growth and patient adherence[3].

Lack of Awareness

Lack of awareness about mental health disorders and available treatments is another challenge that needs to be addressed to fully realize the market potential of venlafaxine[3].

Key Takeaways

• Clinical Success: EFFEXOR® has demonstrated efficacy and safety in treating GAD in Japanese adults, filling a significant unmet medical need.
• Regulatory Pathway: Viatris is set to submit the findings to PMDA in Japan, targeting approval in 2025.
• Market Growth: The venlafaxine market is expected to grow driven by increasing prevalence of anxiety disorders, growing geriatric population, and rising healthcare expenditures.
• Challenges: High drug costs and side effects, along with lack of awareness, are key challenges that need to be addressed.

FAQs

Q1: What was the primary objective of the Phase 3 study of EFFEXOR® in Japan?

The primary objective was to demonstrate the superiority of venlafaxine over placebo in reducing anxiety symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline at 8 weeks.

Q2: How was the safety and tolerability of EFFEXOR® in the Phase 3 study?

EFFEXOR® was generally well tolerated with low discontinuation rates due to treatment-emergent adverse events and no serious or severe intensity adverse events observed.

Q3: What are the market growth drivers for venlafaxine?

The market growth is driven by the increasing prevalence of anxiety disorders, growing geriatric population, rising healthcare expenditures, and increasing government initiatives and awareness.

Q4: What are the challenges facing the venlafaxine market?

High drug costs, side effects associated with venlafaxine, and lack of awareness about mental health disorders are significant challenges.

Q5: What is the projected growth rate of the venlafaxine market?

The global venlafaxine market is projected to grow at a CAGR of 4% from 2022 to 2029.

Sources

1. PR Newswire: Viatris Announces Positive Top-line Results from Phase 3 Study of EFFEXOR in Japanese Adults with Generalized Anxiety Disorder (GAD)[1].
2. Investing.com: Viatris reports positive results for EFFEXOR in Japan GAD study[2].
3. Data Bridge Market Research: Global Venlafaxine Market - Industry Trends and Forecast to 2029[3].
4. Viatris Newsroom: Viatris Announces Positive Top-line Results from Phase 3 Study of EFFEXOR in Japanese Adults with Generalized Anxiety Disorder (GAD)[4].
5. GlobeNewswire: Antidepressant Drugs Market is expected to reach a revenue of USD 26.9 Bn by 2033 at 3.3% CAGR[5].