Shire wins US FDA approval for prescription medicine Mydayis to treat ADHD.
M2 PHARMA-June 21, 2017-Shire wins US FDA approval for prescription medicine Mydayis to treat ADHD
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Biotechnology company Shire plc (LSE:SHP) (NASDAQ:SHPG) reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for Mydayis for the treatment of patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD).
The company said Mydayis (mixed salts of a single-entity amphetamine product) is a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with ADHD. It is not for use in children 12 years and younger.
ADHD is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. The company expects to make Mydayis commercially available in the US in the third quarter of 2017.
US FDA approval of Mydayis is based on results from the company's 16 clinical studies in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD.
Under the company's pivotal, placebo-controlled clinical studies, 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. Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at two or four hours post-dose and lasting up to 16 hours post-dose.
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|Date:||Jun 21, 2017|
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