Reportlinker Adds R&D Trends: Autism Spectrum Disorders - Unknown Etiology and Low Industry Interest Hinders Pipeline Progression
NEW YORK, May 11, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
R&D Trends: Autism Spectrum Disorders - Unknown etiology and low industry interest hinders pipeline progression
Since 2006, two drugs have gained FDA approval for the symptomatic treatment of irritability in autism spectrum disorders (ASDs). However, the pipeline is also characterized by a high attrition rate, with eight pipeline candidates having been discontinued since 2009. CureMark's Phase III candidate, CM-AT, currently represents the most advanced compound in the small ASD 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 the future treatment in autism spectrum disorders including the development of personalized treatments and the use of biomarkers.
The autism spectrum disorders (ASDs) pipeline is 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 and the pipeline is characterized by a high attrition rate.
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.
Your key questions answered
* 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 the conduct of clinical trials in autism spectrum disorders?
* How is the treatment of autism spectrum disorders likely to evolve over the next 10 to 20 years?
Strategic scoping and focus
Datamonitor key findings
CASE STUDY IN AUTISM SPECTRUM DISORDERS
Treatment guidelines for autism spectrum disorders
Treatment should be individualized and systematically monitored
Pharmacological treatment is considered an adjunct to behavioral and psychological intervention
Published treatment guidelines are based on mixed clinical trial data and focus on pediatric patients
First point of influence: increase public awareness in order to drive up patient presentation
Second point of influence: improved primary care physician education will aid earlier diagnosis and intervention
Third point of influence: physician detailing will boost product potential
Opportunities and threats
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Pathology Industry: R&D Trends: Autism Spectrum Disorders - Unknown etiology and low industry interest hinders pipeline progression
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