Shire Agrees to FDA Request to Test ADHD Medication on Preschool Children

Shire, a global innovator in specialty biopharmaceuticals, announced today that they will conduct clinical trials using their amphetamine-based drug, Vyvanse, on preschool children with attention deficit hyperactivity disorder (ADHD).

The London drugmaker agreed to a U.S. Food and Drug Administration (FDA) request to test Vyvanse on children between the ages of four and five. The drug is typically prescribed to those aged six years and above, but ADHD has become more prevalent in U.S. school children over the years and many are left untreated for an extended period of time.

Vyvanse helps control one's ADHD symptoms, and worldwide sales of the drug grew by 18% during the first quarter of this year, grossing $351 million. Shire reports that the estimated prevalence of ADHD in preschool-aged children is between three and five percent and only a small percentage of those children responded well to behavioral therapy.

"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 in a company news release. "Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD."

Vyvanse is only approved for ADHD treatment in the US, Canada, Australia, Mexico, Brazil, and several European countries, most likely because central nervous system (CNS) stimulants can be addictive and abused very easily. This is especially the case when young children or teenagers are prescribed such drugs for various attention disorders. Many parents leave their children off of the medication to prevent dependency issues later in life.

ADHD affects 4.1% of American adults and 9% of American children aged 13 to 18 years, with the average person being diagnosed at the age of seven. Boys are four times as likely to develop the disorder than girls, and it is not known why ADHD is becoming more prevalent among children.

The Shire program for preschool children will include a pharmacokinetic study (for dosing as well as safety and tolerability); an efficacy and safety study; and an open-label study to evaluate long-term safety. Patient safety will be monitored throughout the clinical trials by a Data Monitoring Committee when the trials begin during the first half of 2015.