Adult and adolescent ADHD drug wins US approval

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Shire has won US approval for a long-acting attention deficit drug aimed at adolescents and adults, reports Reuters Health.

The new drug Mydayis, previously known as SHP465, contains the same active ingredient as Shire's widely used attention deficit hyperactivity disorder (ADHD) treatment Adderall XR but is formulated to last up to 16 hours. Adderall XR, which is also available in generic forms, manages symptoms for up to 12 hours.

"It's obviously not a new molecule but it does extend delivery," said Gregory Mattingly, who has been a study investigator in multiple Shire ADHD drug trials. Shire plans to launch Mydayis in the third quarter of 2017.

The report says Mydayis is designed to help those patients, many of them college students or adults, who now take two doses of various ADHD treatments to control their symptoms throughout the day. The drug cannot be used by children aged 12 years or younger.

Shire first filed an application to market Mydayis in 2006 but faced multiple setbacks, including a requirement for additional studies to satisfy the US Food and Drug Administration (FDA).

ADHD is characterised by inattention and/or hyperactivity-impulsivity that affects development. Estimates vary but recent data show up to 11% of US children are afflicted and more than half continue to suffer as adults.

The report asy other ADHD drug developers include Neos Theraputics Inc, Alcobra Ltd, Aevi Genomic Medicine and privately held NLS Pharma.

Reuters Health report

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