Boston, MA -- (SBWIRE) -- 07/04/2012 -- 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.
- 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.
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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
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- How many drugs are in clinical development for the treatment of autism spectrum disorders? What deters companies from investing in this area?
- What symptoms and mechanisms of action are most frequently targeted? What key companies are involved in the pipeline?
- What is the target product profile and most appropriate comparator therapy?
- What are the key challenges in conducting clinical trials in autism spectrum disorders?
- How is the treatment of autism spectrum disorders likely to evolve over the next 10 to 20 years?
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