Shire says trial drug for ADHD shows positive results
pharmafile | June 30, 2016 | News story | Research and Development, Sales and Marketing | ADHD, Shire, US FDA, drug trial, regulation
UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results.
Philip Vickers head of research and development, said: “Shire has been working to fully understand the different needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder. We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD.”
Armed with the results of 16 clinical studies the company plans to file a Class 2 Resubmission of the New Drug Application (NDA) with the US Food and Drug Administration by the end of 2016, Shire said in a statement.
The program is on track for potential U.S. approval in the second half of 2017, the company said.
Attention-Deficit/Hyperactivity Disorder is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.
An estimated 4.4% of adults have ADHD in the US. When applied to the full US adult population aged 18 and over, this translates to about 10.5 million people with the disorder.
Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms.
Anjali Shukla
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