Lisdexamfetamine safe, effective for treating ADHD symptoms in adolescents

Lisdexamfetamine dimesylate was found to be safe and effective for treating attention-deficit/hyperactivity disorder symptoms in adolescents aged 13 to 17 years, according to data presented at the 2010 American Psychiatry Association Annual Meeting in New Orleans.

“These results are important as we look for additional ways to effectively manage ADHD symptoms in adolescent patients,” Ann C. Childress, MD, president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, said in a press release.

The four-week, double blind, phase-3 study included 309 adolescents who were assigned to 30-mg, 50-mg or 70-mg lisdexamfetamine dimesylate (Vyvanse Capsules CII, Shire) daily or placebo; 232 of the study patients recieved the study medication. At baseline, eligible patients had at least moderate ADHD symptoms, defined as an ADHD Rating Scale IV: Clinician Version score (ADHD-RS) of ≥28.

Within the first week, the researchers observed statistically significant changes in ADHD-RS scores in each trial group relative to the placebo group. Improvements in inattention, hyperactivity and impulsivity were noted. At the end of the trial, ADHD-RS had dropped significantly for each dose vs. placebo.

The Clinical Global Impression-Improvement scale (CGI-I), a secondary efficacy measure, indicated that a greater percentage of patients assigned to any dose of lisdexamfetamine dimesylate were very much or much improved at the trial’s endpoint vs. those assigned to placebo (69.1% vs. 39.5%; P<.0001).

The most frequent adverse events, occurring in more than 5% of the population, were headache, decreased appetite, weight loss, irritability and insomnia. The researchers noted small mean increases in pulse and systolic and diastolic blood pressure, but there were no clinically significant trends for electrocardiograms.

Lisdexamfetamine dimesylate is already approved for treating ADHD in adults as well as children aged 6 to 12 years. Shire recently submitted a supplemental New Drug Application for the use of the drug in older adolescents.

The study was supported by funding from Shire.

For more information:

Childress AC. Presented at: 2010 American Psychiatry Association Annual Meeting; May 22-26, 2010; New Orleans.