Shire Plc Set to Test New ADHD Drug on Children
The U.S. Food and Drug Administration (FDA) had requested Shire Plc to conduct a study testing the a stimulant after concerns rose regarding the effectiveness of diagnosing and treating children with attention deficit hyperactivity disorder (ADHD). The company has agreed to the agency's written request and will examine the effects of its stimulant Vyvanse on four- to five-year-old children with ADHD.
"Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients," said Philip Vickers, Ph.D., Head of Research and Development at Shire reported by the Wall Street Journal. "Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD."
Shire Plc is now in the process of designing three clinical trials that will be a part of a larger clinical trial program. The program in general will evaluate the effects of taking Vyvanse on children younger than six. In one of the trials, the focus will be on examining how the body absorbs, breaks down and excretes Vyvanse. In another trial, the researchers will test the drug's safety and efficacy. In the last trial, the goal is to determine whether or not the drug is safe for long-term use.
Vyvanse, along with Shire's Ritalin and Adderall, are currently approved to treat ADHD in children aged six and older. However, younger children often take these medications as well.
ADHD is a neurobehavioral disorder that is characterized by inattention and/or hyperactivity-impulsivity. These behaviors are persistent enough to disrupt a child's learning process and development. A federal report last year revealed that the rate of children diagnosed with ADHD increased 41 percent from 2003 to 2011. In the age group of four to 17, 6.4 percent of them had ADHD.
The first trial is set to start during the first half of 2015.