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Disease Analysis: Bipolar Disorder

  • Report
  • 70 Pages
  • May 2021
  • Region: Global
  • Citeline
  • ID: 5206542
Latest Key Takeaways

  • The publisher 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 sees 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 dosing every two weeks; 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 dosing regimen of once every two weeks, 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 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 mid-2021.
  • Intra-Cellular Therapies submitted a supplemental NDA for Caplyta in the first quarter of 2021 based on a robust safety and tolerability profile along with a positive evidence base demonstrating efficacy in the treatment of BD depression, including type II BD specifically. Similarly, BioXcel’s rolling NDA submission for BXCL501 as a treatment for acute agitation in schizophrenia and BD is complete, and an approval decision is expected in Q4 2021.

Table of Contents

  • Latest key takeaways

  • Definition
  • Patient segmentation

  • 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

  • Prevalence methodology

  • Recent NDA Submissions Include BioXcel’s Dexmedetomidine Oral Film
  • Caplyta Aims For Broad Range In Bipolar Depression Claim
  • 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

  • Sponsors by status
  • Sponsors by phase
  • Recent events
  • Marketed drugs
  • Pipeline drugs

  • 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

  • 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)

  • BD depression
  • Delay of correct diagnosis
  • Cognitive impairment

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: The publisher’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: Key upcoming events in bipolar disorder
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 ($m), 2016–20
Table 5: Forecasted global sales, by drug ($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)