Product Profiles: Autism Spectrum Disorders - Underserved Market Eagerly Anticipates Pipeline Trial Data

14 Jul 2011 • by Natalie Aster

“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 approval Abilify for the same indication. In 2008, generic risperidone launched following Risperdal’s US patent expiry.”

The report “Product Profiles: Autism Spectrum Disorders -Underserved Market Eagerly Anticipates Pipeline Trial Data” by Datamonitor provides an overview of marketed and pipeline drugs in clinical development for autism spectrum disorders.

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 III trial data necessary for the clinical assessment of these compounds.

Report Details:

Product Profiles: Autism Spectrum Disorders -Underserved Market Eagerly Anticipates Pipeline Trial Data

Published: June 2011

Pages: 46

Price: US$ 11,400.00

Report Sample Abstract

More favorable side-effect profile attributed to unique mechanism of action is key differentiator

Compared to other atypical antipsychotics which antagonize D2 receptors, Abilify’s partial agonism of the same receptors is thought to account for its superior side-effect profile. Clinical trial data demonstrate that compared to Risperdal, Abilify confers a more favorable side-effect profile with regard to appetite, weight gain, and sedation. A large proportion of patients receiving Risperdal reported increased appetite compared to placebo (64% versus 24%) (McCracken et al., 2002; Pandina et al., 2007), whereas Abilify was associated with decreased appetite compared to placebo (7% versus 2%). Interestingly, a slight weight gain was observed with Abilify treatment, with a mean 1.6kg increase in weight gain compared to placebo 0.4kg (Owen et al., 2009; Marcus et al., 2009). With regard to sedation, 21% of patients on Abilify reported sedation, while 88% and 55% of patients experienced somnolence and fatigue, respectively, when taking Risperdal. Datamonitor believes that Abilify’s superior side-effect profile is a key factor differentiating the product from the other atypical antipsychotics.

Key opinion leaders reiterate that side effects such as weight gain are considered a much greater issue with Risperdal treatment.

Clinical trial data indicate superior efficacy to competitor Abilify yet more severe side effects

Pivotal clinical trial data demonstrate that Risperdal is associated with superior efficacy on the ABC-I response compared to Abilify (Risperdal -13.4 to -14.9 versus Abilify -8.4 to -14.4; McCracken et al., 2002; Pandina et al., 2007; Owen et al., 2009; Marcus et al., 2009). However, the percentage of patients reporting side effects is greater in the Risperdal-treated group.

Pivotal clinical trial data demonstrate that a high percentage of patients treated with Risperdal experience somnolence (88%) and increased appetite (64%), compared to patients on Abilify who experience somnolence (16%) and increased appetite (7%). In fact, treatment with Abilify also leads to decreased appetite, experienced by 4% of patients (for more information on clinical profiles see the development overview sections for both Abilify and Risperdal). Although key opinion leaders comment on Risperdal being a very effective drug, they also recognize that the clinical trial data favor Risperdal due to the design of the trials being in treatment-naive populations (for more information, see the section titled Clinical and commercial attractiveness of Abilify). Furthermore, they note problems associated with the side effects prevalent with Risperdal treatment.

Despite positive early-stage Phase II results, Datamonitor is unable to reliably analyze the candidate’s clinical efficacy due to the lack of publicly available late Phase II clinical trial data. However, Datamonitor believes that the publication of clinical trial data from the ongoing late stage Phase II clinical trial (see Figure 7) will further clarify the candidates use in the management of ASDs symptoms. Key opinion leaders comment on the scientific rationale behind GABAb agonists and the potential use for STX-209 in the management of ASDs, highlighting the need for more clinical trial data.

More information can be found in the report “Product Profiles: Autism Spectrum Disorders -Underserved Market Eagerly Anticipates Pipeline Trial Data” by Datamonitor.

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