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Disease Analysis: Bipolar Disorder

Published by Datamonitor Healthcare Product code 991712
Published Content info 73 Pages
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Disease Analysis: Bipolar Disorder
Published: February 11, 2021 Content info: 73 Pages
Description

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 46.2 million prevalent cases of bipolar disorder (BD) worldwide, and forecasts that number to increase to 50.4 million prevalent cases by 2027.

The BD market is highly genericized, consisting of antipsychotics, anticonvulsants, and mood stabilizers such as lithium. The atypical antipsychotic market is the most dominant of the drug classes indicated for BD, and the oral atypical antipsychotic market is highly competitive with many generic alternatives available. The atypical long-acting injectable (LAI) antipsychotic market currently faces little competition and is therefore one of the key areas to target for growth, along with the development of drugs focusing on other underserved BD patient segments.

Some of the most impactful recent events that have occurred in the BD space include the complete response letter (CRL) issued by the FDA for Alkermes's Lybalvi (ALKS 3831), despite the positive outcomes from the October 2020 advisory committee meeting. Additionally, Intra-Cellular Therapies' Caplyta and BioXcel's BXCL501 have provided positive topline pivotal trial results in BD depression and acutely agitated BD patients, respectively. BioXcel has since initiated a rolling NDA submission for BXCL501.

As physicians and patients become more accustomed to the dosing regimens of LAIs and their associated benefits, their uptake will increase. Pharmaceutical treatment compliance is a major issue in BD, and physicians will encourage switching to LAI formulations to reduce relapses. There are only two key brands in the BD LAI atypical antipsychotic market: Risperdal Consta, the first of its kind approved for BD, requiring biweekly dosing; and Abilify Maintena, which only requires once-monthly administration.

Seroquel/Seroquel XR has a robust clinical profile in BD due to its strong efficacy as both a monotherapy and adjuvant in the treatment of BD mania, as a BD maintenance treatment, and in BD depression. The drug is one of few therapies specifically approved for BD depression. As a monotherapy in trials, treatment in both type I and II BD patients elicited some of the greatest improvements over placebo that have been witnessed in controlled BD studies. As an atypical antipsychotic, Seroquel/Seroquel XR has modest safety/tolerability profiles at best. Nevertheless, both formulations are genericized, and the market share of this brand in BD has been cannibalized and will continue to plummet.

Abilify Maintena is one of the few approved LAI antipsychotics available for BD, and its increasing uptake means it is likely to dominate the bipolar LAI market. The drug boasts one of the highest rates of relapse reduction over placebo in clinical trials, granting it a position towards the top of the BD maintenance treatment algorithm. Abilify Maintena can be administered once-monthly, surpassing Risperdal Consta's biweekly dosing regimen, and this less frequent dosing provides further aid to the mitigation of compliance issues so often seen with antipsychotics. With the associated benefits of LAIs, and as both physicians and patients become more accustomed to the dosing regimens, the LAI market should see sizable growth.

Pipeline drug developers are targeting unmet needs in BD for which there are currently limited options available, and consequently, these pipeline drugs will act to drive growth in the market, if successfully approved. Intra-Cellular Therapies has gathered encouraging data from trials investigating the adjunctive and monotherapy use of Caplyta in type I and II BD depression patients. Only Latuda is approved as an adjunctive/monotherapy treatment for BD depression, and also has demonstrable efficacy in type II BD depressed patients, specifically. Intra-Cellular would therefore be offering another much-needed option in this subpopulation, and, moreover, Caplyta displayed minimal motor adverse events in pivotal trials, compared to the higher rates witnessed in Latuda's regulatory studies.

Alkermes's Lybalvi, a distinct formulation of olanzapine and the novel opioid receptor antagonist samidorphan, is an antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain, a firmly established side effect of most antipsychotics. In trials, the drug has demonstrated similar efficacy to olanzapine in schizophrenia patients and a statistically significant reduction in weight gain. Despite a positive FDA Advisory Committee meeting in October 2020, the FDA issued Alkermes with a CRL due to discrepancies with the manufacturing data submitted; nonetheless, Alkermes predicts an approval decision will likely come in the first half of 2021.

In addition to the FDA's second review decision on Alkermes's Lybalvi, a further key upcoming event in the BD space is Intra-Cellular Therapies' projected sNDA submission for Caplyta in the treatment of BD depression, including BD type II specifically. Similarly, BioXcel's rolling NDA submission for BXCL501 as a treatment for acute agitation in schizophrenia and BD is expected to be fully submitted by the end of the first quarter of 2021.

Table of Contents
Product Code: DMKC0219684

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

  • Drug therapy is used in the vast majority of bipolar disorder patients
  • Therapy can be integrated with non-pharmacological interventions to improve patient outcomes
  • The goal of treatment is to bring patients to a state of recovery and minimize relapses
  • Bipolar disorder treatment guideline recommendations by drug class
  • Acute mania
  • Acute depression
  • Maintenance therapy

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections
  • Alkermes' Antipsychotic Clears US FDA Panel Amid Calls For Broader Professional Education Plan
  • 12 Approvals To Look Out For In Q4
  • Alkermes' Antipsychotic Combo Faces US FDA Questions On Metabolic Effects, Opioid-Related Safety

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Marketed drugs
  • Pipeline drugs

MARKET DYNAMICS

FUTURE TRENDS

  • The LAI atypical antipsychotic market will see increasing growth and little competition
  • The oral atypical antipsychotic market will see further widespread genericization
  • Potential market entrants will be directed towards underserved patient segments and improved tolerability

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Falkieri for Bipolar Disorder (January 8, 2021)
  • Lybalvi for Bipolar Disorder (October 9, 2020)
  • Lybalvi for Bipolar Disorder (October 7, 2020)
  • Caplyta for Bipolar Disorder (September 9, 2020)
  • BXCL501 for Bipolar Disorder (July 20, 2020)
  • SEP-4199 for Bipolar Disorder (July 6, 2020)
  • SAGE-217 for Bipolar Disorder (July 24, 2019)
  • Caplyta for Bipolar Disorder (July 8, 2019)

KEY UPCOMING EVENTS

UNMET NEEDS

  • BD depression
  • Delay of correct diagnosis
  • Cognitive impairment

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: DSM-5 diagnostic criteria for mood episodes based on symptoms
  • Figure 2: DSM-5 diagnostic criteria for bipolar disorder subtypes
  • Figure 3: Psychological interventions for bipolar disorder
  • Figure 4: Guidelines for bipolar disorder treatment
  • Figure 5: Drug classes recommended in bipolar disorder treatment guidelines, by disease phase and line of therapy
  • Figure 6: Guideline recommendations for acute mania, by line of treatment
  • Figure 7: Guideline recommendations for acute depression, by line of treatment
  • Figure 8: Guideline recommendations for maintenance therapy, by line of treatment
  • Figure 9: Trends in prevalent cases of bipolar disorder, 2018-27
  • Figure 10: Overview of pipeline drugs for bipolar disorder in the US
  • Figure 11: Pipeline drugs for bipolar disorder, by company
  • Figure 12: Pipeline drugs for bipolar disorder, by drug type
  • Figure 13: Pipeline drugs for bipolar disorder, by classification
  • Figure 14: Probability of success in the bipolar disorder pipeline
  • Figure 15: Clinical trials in bipolar disorder
  • Figure 16: Top 10 drugs for clinical trials in bipolar disorder
  • Figure 17: Top 10 companies for clinical trials in bipolar disorder
  • Figure 18: Trial locations in bipolar disorder
  • Figure 19: Bipolar disorder trials status
  • Figure 20: Bipolar disorder trials sponsors, by phase
  • Figure 21: Datamonitor Healthcare's drug assessment summary for bipolar disorder
  • Figure 22: Market dynamics in bipolar disorder
  • Figure 23: Future trends in bipolar disorder
  • Figure 24: Falkieri for Bipolar Disorder (January 8, 2021): Phase II - Treatment-Resistant Bipolar Depression
  • Figure 25: Caplyta for Bipolar Disorder (September 9, 2020): Phase III - Study 402 (Adjunctive)
  • Figure 26: BXCL501 for Bipolar Disorder (July 20, 2020): Phase III - SERENITY II
  • Figure 27: SEP-4199 for Bipolar Disorder (July 6, 2020): Phase II - SEP380-201
  • Figure 28: Caplyta for Bipolar Disorder (July 8, 2019): Phase III - Study 401 (Monotherapy), Phase III - Study 404 (Monotherapy)
  • Figure 29: Key upcoming events in bipolar disorder

LIST OF TABLES

  • Table 1: Prevalent cases of bipolar disorder, 2018-27
  • Table 2: Marketed drugs for bipolar disorder
  • Table 3: Pipeline drugs for bipolar disorder in the US
  • Table 4: Historical global sales, by drug ($m), 2015-19
  • Table 5: Forecasted global sales, by drug ($m), 2021-25
  • Table 6: Falkieri for Bipolar Disorder (January 8, 2021)
  • Table 7: Lybalvi for Bipolar Disorder (October 9, 2020)
  • Table 8: Lybalvi for Bipolar Disorder (October 7, 2020)
  • Table 9: Caplyta for Bipolar Disorder (September 9, 2020)
  • Table 10: BXCL501 for Bipolar Disorder (July 20, 2020)
  • Table 11: SEP-4199 for Bipolar Disorder (July 6, 2020)
  • Table 12: SAGE-217 for Bipolar Disorder (July 24, 2019)
  • Table 13: Caplyta for Bipolar Disorder (July 8, 2019)
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