Elvanse (lisdexamphetamine dimesylate)
Elvanse (lisdexamphetamine dimesylate) is a stimulate drug indicated as a part of a comprehensive treatment program for the treatment of ADHD in patients older than 6 years when the patient has not responded adequately to methylphenidate. The prodrug design slowly releases the active compound, dexamphetamine, and the duration of action is between 13 and14 hours. The starting dose is 30 mg daily regardless of any previous treatment. Maximum daily dose is 70 mg.
Compared to placebo, Lisdexamphetamine has a significant effect on ADHD core symptoms in children, adolescents and adults. The effect in children and adolescents is comparable to long-acting methylphenidate. Functional abilities are more readily improved with lisdexamphetamine than atomoxetine. Long term effects on ADHD core symptoms and functional capacity are not well documented.
The most frequent adverse events are comparable to those of long acting methylphenidate. As in the case of other stimulant drugs, there is a risk of dependency and abuse. It has been shown that lisdexamphetamine may inhibit children’s growth. A potential cardiac risk of stimulant substances is investigated by US drug authorities.
It is IRF’s overall assessment that lisdexamphetamine is a clinically relevant second line treatment option, although atomoxetine should still be preferred when there is a risk of drug abuse.
Elvanse was marketed in Denmark April 15th 2013. It is currently possible to apply for single reimbursement.