Over the past 6 years, three major events have impacted the autism spectrum
disorders market. In 2006, Risperdal became the first drug to receive approval
from the US FDA for the symptomatic treatment of irritability in children and
adolescents with ASDs. Later, in 2009, the FDA approved Abilify for the same
indication. In 2008, generic risperidone launched following Risperdal's US
patent expiry.
Features and benefits
Overview of marketed and pipeline drugs in clinical development for autism
spectrum disorders.
Analysis of the market positioning of each product approved for the
treatment of autism spectrum disorders.
Assessment of the strengths, weaknesses, opportunities, and threats for
marketed and late-stage pipeline candidates.
Summary of the clinical and commercial attractiveness for each of the
marketed products.
Insight from key opinion leaders on marketed and pipeline products.
Highlights
Risperdal and Abilify are the only two products approved for the treatment of
autism spectrum disorders (ASDs). Both of these atypical antipsychotics are
indicated for the management of irritability symptoms associated with ASDs in
the US. Due to the failure of these drugs to address the core symptoms of
ASDs, many other drugs are used off-label.
Abilify is the most recent entrant to the ASDs market, having received US Food
and Drug Administration (FDA) approval in November 2009. The drug's partial
agonism of dopamine receptors unique mechanism of action is considered a key
differentiating factor, producing a superior side-effect profile compared to
other atypical antipsychotics.
To date, none of the four late-stage pipeline candidates for autism spectrum
disorders has publically presented the late-stage Phase II or Phase III trial
data necessary for the clinical assessment of these compounds.
Your key questions answered
What are the key differentiating features of approved therapies for the
treatment of autism spectrum disorders?
How do key opinion leaders perceive available treatments for autism
spectrum disorders?
What opportunities are there for existing players in the autism spectrum
disorders market to increase their market share?
What is the development status of current pipeline candidates?
What clinical trial designs are current pipeline candidates following?
What do pipeline candidates need to demonstrate in order to be successful?
Figure: Phase II clinical trial of STX-209 for autism spectrum disorders
Figure: Ongoing late Phase II clinical trial of STX-209 for autism
spectrum disorders
Figure: The PharmaVitae Explorer
Product Profiles: Autism Spectrum Disorders - Growing interest in underserved market published by Datamonitor in April 26, 2012. This report consists of Pages: 59 and the price starts from US $ 3800.
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