CLINICAL TRIALS PROFILE FOR VRAYLAR

All Clinical Trials for VRAYLAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02670538 ↗	Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder	Completed	Forest Laboratories	Phase 3	2016-03-31	This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT02670551 ↗	Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression	Completed	Forest Laboratories	Phase 3	2016-03-17	This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT02670551 ↗	Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression	Completed	Forest Laboratories, LLC, an Allergan Affiliate	Phase 3	2016-03-17	This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT04771299 ↗	Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients	Recruiting	Jayasree Basivireddy	Phase 3	2021-07-07	Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR®) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.
NCT04777357 ↗	A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder	Recruiting	Allergan	Phase 3	2021-04-28	Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Clinical Trial Conditions for VRAYLAR

Condition Name

Condition Name for VRAYLAR
Intervention	Trials
Depression	3
Bipolar Disorder	2
Bipolar I Disorder	2
Cognitive Impairment	1

Condition MeSH

Condition MeSH for VRAYLAR
Intervention	Trials
Disease	4
Depressive Disorder	4
Depression	4
Bipolar Disorder	3

Clinical Trial Locations for VRAYLAR

Trials by Country

Trials by Country for VRAYLAR
Location	Trials
United States	79
Japan	20
Romania	4
Serbia	4
Ukraine	3

Trials by US State

Trials by US State for VRAYLAR
Location	Trials
New York	6
Texas	5
Ohio	5
Illinois	5
Florida	5

Clinical Trial Progress for VRAYLAR

Clinical Trial Phase

Clinical Trial Phase for VRAYLAR
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for VRAYLAR
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	2
Completed	2

Clinical Trial Sponsors for VRAYLAR

Sponsor Name

Sponsor Name for VRAYLAR
Sponsor	Trials
AbbVie	3
Forest Laboratories	2
Allergan	2

Sponsor Type

Sponsor Type for VRAYLAR
Sponsor	Trials
Industry	8
Other	3

VRAYLAR Market Analysis and Financial Projection

VRAYLAR: Clinical Trials, Market Analysis, and Projections

Introduction to VRAYLAR

VRAYLAR, also known as cariprazine, is an atypical antipsychotic drug developed by Allergan (now part of AbbVie) and Gedeon Richter. It is approved for the treatment of schizophrenia, bipolar disorder, and as an adjunctive treatment for major depressive disorder (MDD).

Clinical Trials Update

Bipolar Disorder Trials

VRAYLAR has been extensively studied in clinical trials for its efficacy in treating bipolar disorder. Three 3-week, randomized, double-blind, placebo-controlled trials were conducted in adult patients with bipolar I disorder with manic or mixed episodes. The primary endpoint was the change from baseline to week 3 in the Young Mania Rating Scale (YMRS) total score. The results showed that VRAYLAR significantly reduced YMRS scores compared to the placebo, demonstrating its efficacy in managing manic symptoms[4].

Major Depressive Disorder Trials

In recent Phase 3 clinical trials (Study 3111-301-001 and Study 3111-302-001), VRAYLAR met its primary endpoint as an adjunctive treatment for MDD. These trials demonstrated a statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores, highlighting VRAYLAR's potential in treating MDD[1].

Mechanism of Action

VRAYLAR works through a unique mechanism involving partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2A receptors. This multifaceted action contributes to its therapeutic effects in various psychiatric conditions[2].

Market Analysis

Current Market Position

The US market for major depressive disorders is projected to grow significantly, with atypical antipsychotics like VRAYLAR playing a crucial role. In 2015, atypical antipsychotics generated 39% of the sales in the US MDD market, and this trend is expected to continue. VRAYLAR, along with other drugs like Rexulti, is anticipated to contribute substantially to this market segment[5].

Marketing Strategies

AbbVie has been aggressive in its marketing efforts for VRAYLAR, particularly through direct-to-consumer (DTC) advertising. This approach has been successful in increasing patient activation and the drug's share of voice in the market. In November 2023 alone, AbbVie spent $13.1 million on VRAYLAR ads, making it one of the leading drugs in terms of DTC spend[2].

Competitive Landscape

The psychiatric drug market is crowded and fragmented, with numerous available medicines. However, VRAYLAR's unique mechanism of action and broad label indications set it apart. The acquisition of Cerevel by AbbVie, which includes the midstage pipeline drug emraclidine, further strengthens AbbVie's position in the psychiatric market. Emraclidine, though different in mechanism, is expected to complement VRAYLAR's market presence[2].

Market Projections

Sales Forecast

The market forecast for VRAYLAR is promising, especially in the treatment-resistant depression segment. According to DelveInsight's report, the market for VRAYLAR in seven major markets (the United States, EU5, and Japan) is expected to grow significantly from 2023 to 2032. The report provides detailed sales forecasts, indicating that VRAYLAR will remain a key player in the treatment-resistant depression market[3].

Emerging Therapies

The landscape for treatment-resistant depression is evolving with the development of new therapies. While VRAYLAR faces competition from emerging products, its established presence and ongoing research activities position it well for continued market dominance. Other late-stage emerging therapies, such as ALKS-5461 and AXS-05, will also enter the market, but VRAYLAR's strong marketing and clinical profile are expected to maintain its market share[3][5].

Regulatory Milestones and Development Activities

VRAYLAR has achieved several regulatory milestones, including approvals for its various indications. The drug continues to be under active development, with ongoing clinical trials and regulatory activities aimed at expanding its label and improving patient outcomes. The acquisition by AbbVie and the integration of Cerevel's pipeline further enhance VRAYLAR's developmental trajectory[3].

Key Takeaways

• Clinical Efficacy: VRAYLAR has demonstrated significant efficacy in clinical trials for bipolar disorder and major depressive disorder.
• Market Position: It holds a strong position in the US MDD market, driven by aggressive marketing strategies.
• Mechanism of Action: Its unique mechanism involving dopamine and serotonin receptors sets it apart from other antipsychotics.
• Market Projections: Sales forecasts indicate continued growth through 2032, despite emerging competition.
• Regulatory and Development Activities: Ongoing clinical trials and regulatory efforts are expected to further solidify VRAYLAR's market presence.

FAQs

What are the approved indications for VRAYLAR?

VRAYLAR is approved for the treatment of schizophrenia, bipolar disorder (manic or mixed episodes), and as an adjunctive treatment for major depressive disorder (MDD)[1][4].

How does VRAYLAR work?

VRAYLAR works through partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2A receptors[2].

What is the current market spend on VRAYLAR advertising?

AbbVie has significantly increased its DTC advertising spend on VRAYLAR, with $13.1 million spent in November 2023 alone[2].

What are the projected sales forecasts for VRAYLAR?

Sales forecasts indicate that VRAYLAR will continue to grow in the treatment-resistant depression market, with significant sales projected through 2032[3].

How does VRAYLAR compare to other psychiatric drugs in the market?

VRAYLAR's unique mechanism of action and broad label indications set it apart. It faces competition from emerging therapies but remains a key player due to its established presence and strong marketing efforts[2][3].

Sources

1. AbbVie's Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for Major Depressive Disorder. AbbVie News, October 29, 2021.
2. AbbVie to tap Vraylar messaging lessons, but also create a new position to promote key psychiatric med. FiercePharma, December 8, 2023.
3. VRAYLAR Emerging Drug Insight and Market Forecast – 2032. DelveInsight.
4. Drug Trials Snapshots: VRAYLAR for the treatment of bipolar disorder, manic/mixed episode. FDA, May 9, 2017.
5. Depression Drugs Sales in the US to Reach $4.6 billion by 2025. Pharmaceutical Executive, October 24, 2016.