David Baxter PhD
Late Founder
FDA Approves ADHD Drug for Maintenance Treatment in Kids
by Deborah Brauser, Medscape
May 02, 2013
The US Food and Drug Administration (FDA) has approved lisdexamfetamine dimesylate (Vyvanse, Shire Plc) for maintenance treatment in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). It was previously approved for maintenance treatment only in adults with ADHD.
According to a company release, the approval makes lisdexamfetamine dimesylate the only stimulant approved for maintenance in all individuals with ADHD older than 6 years.
"It's important to help establish and maintain effective control of symptoms in patients with ADHD," said Valerie Arnold, MD, from CNS Healthcare of Memphis, Tennessee, in the same release.
Dr. Arnold was an investigator in a recent 32-week study that included a 6-week randomized withdrawal phase that assessed the efficacy of the medication in participants between the ages of 6 and 17 years. It showed a significantly lower treatment failure rate in those receiving the active medication (15.8%) vs those receiving placebo (67.5%).
This week's FDA approval is based on the results from this trial.
"This additional approval of Vyvanse is welcome because children and adolescents with ADHD may have a need for extended treatment and could benefit from a treatment option proven to maintain efficacy," said Dr. Arnold.
"This study is evidence of Shire's commitment to conducting research in ADHD and contributing to the body of knowledge about treatment options," added Arnaud Partiot, MD, PhD, senior vice president and head of research and development for Shire.
The medication was introduced in the United States in July 2007 for the treatment of children with ADHD and was approved by the FDA in April 2008 to treat adults with the disorder.
In November 2010, as reported at the time by Medscape Medical News, it was approved to treat adolescents between the ages of 13 and 17, and in January 2012, it was approved as maintenance treatment in adults.
Lisdexamfetamine dimesylate is currently available in once-daily doses of between 20 mg and 70 mg.
by Deborah Brauser, Medscape
May 02, 2013
The US Food and Drug Administration (FDA) has approved lisdexamfetamine dimesylate (Vyvanse, Shire Plc) for maintenance treatment in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). It was previously approved for maintenance treatment only in adults with ADHD.
According to a company release, the approval makes lisdexamfetamine dimesylate the only stimulant approved for maintenance in all individuals with ADHD older than 6 years.
"It's important to help establish and maintain effective control of symptoms in patients with ADHD," said Valerie Arnold, MD, from CNS Healthcare of Memphis, Tennessee, in the same release.
Dr. Arnold was an investigator in a recent 32-week study that included a 6-week randomized withdrawal phase that assessed the efficacy of the medication in participants between the ages of 6 and 17 years. It showed a significantly lower treatment failure rate in those receiving the active medication (15.8%) vs those receiving placebo (67.5%).
This week's FDA approval is based on the results from this trial.
"This additional approval of Vyvanse is welcome because children and adolescents with ADHD may have a need for extended treatment and could benefit from a treatment option proven to maintain efficacy," said Dr. Arnold.
"This study is evidence of Shire's commitment to conducting research in ADHD and contributing to the body of knowledge about treatment options," added Arnaud Partiot, MD, PhD, senior vice president and head of research and development for Shire.
The medication was introduced in the United States in July 2007 for the treatment of children with ADHD and was approved by the FDA in April 2008 to treat adults with the disorder.
In November 2010, as reported at the time by Medscape Medical News, it was approved to treat adolescents between the ages of 13 and 17, and in January 2012, it was approved as maintenance treatment in adults.
Lisdexamfetamine dimesylate is currently available in once-daily doses of between 20 mg and 70 mg.
