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.
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.
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