R&D Trends: Autism Spectrum Disorders – Pipeline growth reflects increasing interest in autism

2012-04-24
Published : Apr-2012

The autism spectrum disorders (ASDs) market is a challenging one to penetrate; since 2006 only two products have been successful in entering this marketplace: Risperdal (risperidone; Johnson & Johnson) and Abilify (aripiprazole; Bristol-Myers Squibb). However, as additional agents near the market, increasing interest in ASDs has led to a sizable growth in the clinical pipeline.

Features and benefits

  • Overview of drugs in late- and early-stage clinical development for autism spectrum disorders.
  • Identification of the target product profile for future autism spectrum disorders treatments.
  • Summary of clinical trial design in autism spectrum disorders including exploration of key endpoints and assessment methodology.
  • Identification of key challenges associated with the conduct of clinical trials in autism spectrum disorders.
  • Exploration of future treatment in autism spectrum disorders including the development of personalized treatments and the use of biomarkers.

Highlights

The autism spectrum disorders (ASDs) pipeline remains sparse relative to other conditions that are treated with psychotropic medications. The unknown etiology of ASDs poses a fundamental challenge to the therapeutic discovery process. However, the pipeline growth is encouraging and reflects an increased interest in ASDs.

The two approved therapies for the management of autism spectrum disorders both target the symptoms of irritability. The comparator therapy identified by Datamonitor is Risperdal (risperidone; Johnson & Johnson) as it was the first to be approved in this indication, demonstrates a strong efficacy profile, and is regarded as a first-line therapy.

Key challenges associated with the conduct of clinical trials in autism spectrum disorders are: the unknown etiology of the disorders and heterogeneous symptomology. Communication and language impairments commonly associated with autism spectrum disorders further compound these challenges.

R&D Trends in Autism Spectrum Disorders

Published: April 2012
No. of Pages: 62


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Table Of Contents

OVERVIEW
Catalyst
Summary

EXECUTIVE SUMMARY
Update details: April 2012
Strategic scoping and focus
Datamonitor key findings
Related reports

CLINICAL PIPELINE OVERVIEW
Overview of the autism spectrum disorders pipeline
The sparse autism pipeline demonstrated encouraging growth and progression over April 2011 to April 2012
Emerging features of the autism spectrum disorders clinical pipeline
Classification of pipeline products
Each of the eight pipeline candidates targets a different mechanism of action
Companies involved in the autism spectrum disorders clinical pipeline
Pipeline activity is dominated by small, specialist pharmaceutical companies
Late-stage development compounds recently discontinued
Pipeline failures prevalent due to unknown etiology of autism spectrum disorders

TARGET PRODUCT PROFILE
Clinical targets
Clinical trial data indicate a lack of efficacy of investigated therapies
Although superior to Risperdal, side effects are also prominent with Abilify treatment
Ease of administration is a key consideration in the development of treatments for the pediatric population
Comparator therapy: Risperdal (risperidone; Johnson & Johnson)
Risperdal was the first drug to receive FDA approval for irritability associated with autistic disorder
Clinical trial data for Risperdal
Target product profile versus current level of attainment
Target product for the treatment of irritability should demonstrate superior efficacy and side effect-profile to Risperdal

CLINICAL TRIAL DESIGN IN AUTISM SPECTRUM DISORDERS
Use of clinical trial endpoints varies according to the target behavioral symptom
Core symptoms
Repetitive behavior
Irritability
ADHD symptoms
Social impairment
Typical clinical trial design
Key challenges in the conduct of clinical trials in autism spectrum disorders
Unknown etiology of autism spectrum disorders hinders selection of appropriate targets
Heterogeneity of symptomatology complicates patient subgroup identification
Conduct of trials in children and young adolescents is complicated by communication difficulties
Future developments in clinical trial design
Clinical trials are likely to include adult autism spectrum disorder patients in the future
Increased patient selection will help to increase response rates in clinical trials

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