Biotechnology company Shire has received the US Food and Drug Administration (FDA) approval for Mydayis (mixed salts of a single-entity amphetamine product) for the treatment of attention deficit hyperactivity disorder (ADHD).
The once-daily Mydayis treatment comprises three different types of drug-releasing beads, and is used for ADHD patients aged 13 years and above. It cannot be used on children aged 12 years and under.
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ADHD is a neurodevelopmental disorder that shows as a persistent pattern of inattention and/or hyperactivity-impulsivity that affects functioning or development.
In the US, the company intends to begin commercialisation of Mydayis in the third quarter of this year.
The approval is based on results from 16 clinical studies analysing the effect of Mydayis in more than 1,600 patients, including adolescents aged between 13 to 17 years and adults with ADHD.
In pivotal, placebo-controlled clinical studies, the therapy showed significant improvements in symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents.
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By GlobalDataIn pivotal Phase III clinical studies, where efficacy was the primary endpoint, a morning dose of Mydayis showed superiority to placebo based on the change from baseline in the ADHD-RS-IV total score for adult and adolescent patients respectively.
The Phase II studies, which included two studies in adults and one in adolescents, demonstrated that patients treated with Mydayis reported improved attention compared to placebo, as assessed by the total PERMP score, with results reaching statistical significance beginning at two or four hours after administering the dose, and lasting up to 16h post-dose.
