Regulatory Affairs

Shire gets FDA approval for ADHD drug Mydayis

PBR Staff Writer Published 22 June 2017

Shire has secured approval from the US Food and Drug Administration (FDA) for its Mydayis (mixed salts of a single-entity amphetamine product) to control attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.

Mydayis is a once-daily treatment and prescription medicine, which includes three different types of drug-releasing beads to control ADHD in patients 13 years and older.

Shire plans to commercially introduce Mydayis in the US in the third quarter of this year.

The approval was based on results from 16 clinical studies that assessed Mydayis in around 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD.

According to the company, Mydayis significantly improved symptoms of ADHD as measured by the ADHD-RS-IV and the permanent product measure of performance (PERMP) in adults and adolescents in pivotal and placebo-controlled clinical studies.

In pivotal phase 3 clinical studies, 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.

In Phase 2 studies (two studies in adults and one in adolescents), patients treated with Mydayis showed improved attention compared to placebo, as evaluated by the total PERMP score, with results reaching statistical significance beginning at 2 or 4 hours post-dose, and lasting up to 16 hours post-dose.

Shire CEO Dr Flemming Ornskov said: “Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD. It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD.

“With this approval, we hope to help patients who need a once-daily treatment option. Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose.”

Image: Shire location in Lexington Massachusetts. Photo: courtesy of John Phelan.