FDA Approves Lisdexamfetamine for Teenagers With ADHD

Yael Waknine

November 16, 2010

November 16, 2010 — The US Food and Drug Administration (FDA) has approved lisdexamfetamine dimesylate capsules (Vyvanse; Shire Pharmaceuticals, Inc) for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.

"This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms," said Mike Yasick, senior vice president of Shire's ADHD Business, in a company news release.

FDA approval was based on data from a double-blind, 4-week, randomized, forced-dose escalation study of 314 adolescents showing that lisdexamfetamine doses of 30, 50, and 70 mg/day significantly improved ADHD symptoms relative to placebo, as evaluated using the ADHD Rating Scale-IV.

Treatment in adolescents was generally safe and well-tolerated. Adverse events were similar to those observed in other populations, with loss of appetite, insomnia, and weight loss most commonly reported.

The recommended initial dose of lisdexamfetamine for patients starting treatment for the first time or switching from another medication is 30 mg once daily in the morning. Daily dosage may be adjusted in increments of 10 or 20 mg at approximately weekly intervals to a maximum of 70 mg/day.

As with other stimulants, lisdexamfetamine carries a boxed warning regarding the risk for sudden death and serious cardiovascular events. The federally controlled substance is subject to misuse and abuse and should be stored in a safe place.

Lisdexamfetamine previously was approved for the treatment of ADHD in adults and children aged 6 to 12 years.

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