Treatment for ADHD with Less Addictive Medications
Psychiatric Times
By Peggy Peck Feb 27, 2007
ROCKVILLE, Md., Feb. 27 -- The FDA has approved lisdexamfetamine dimesylate (Vyvanse), formerly known as NRP104, for attention deficit hyperactivity disorder.
The amphetamine, to be marketed by Shire, is said to have limited abuse potential, but it was designated Schedule II by the DEA. Shire plc said in a statement that the drug has a lower potential for abuse than other amphetamines used to treat ADHD.
"The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of Vyvanse, which illustrate benefits that differentiate this compound from other ADHD medicines," said Matthew Emmens, Shire's CEO.
Data from phase II and phase III clinical trials demonstrated statistically significant improvements in ADHD symptoms for patients ages six to 12 years treated with lisdexamfetamine compared to patients treated with placebo. These studies demonstrated significant efficacy at all time points tested (including 6 p.m.) for doses of 30 mg, 50 mg, and 70 mg.
In the phase II, analog classroom study, patients showed significantly improved behavior when receiving either lisdexamfetamine or Adderall XR (another Shire drug) as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale, a standardized, validated classroom assessment tool used for evaluating ADHD behavioral symptoms.
See Psychiatric Times for more information.......
By Peggy Peck Feb 27, 2007
ROCKVILLE, Md., Feb. 27 -- The FDA has approved lisdexamfetamine dimesylate (Vyvanse), formerly known as NRP104, for attention deficit hyperactivity disorder.
The amphetamine, to be marketed by Shire, is said to have limited abuse potential, but it was designated Schedule II by the DEA. Shire plc said in a statement that the drug has a lower potential for abuse than other amphetamines used to treat ADHD.
"The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of Vyvanse, which illustrate benefits that differentiate this compound from other ADHD medicines," said Matthew Emmens, Shire's CEO.
Data from phase II and phase III clinical trials demonstrated statistically significant improvements in ADHD symptoms for patients ages six to 12 years treated with lisdexamfetamine compared to patients treated with placebo. These studies demonstrated significant efficacy at all time points tested (including 6 p.m.) for doses of 30 mg, 50 mg, and 70 mg.
In the phase II, analog classroom study, patients showed significantly improved behavior when receiving either lisdexamfetamine or Adderall XR (another Shire drug) as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale, a standardized, validated classroom assessment tool used for evaluating ADHD behavioral symptoms.
See Psychiatric Times for more information.......
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