Lisdexamfetamindimesilat (Elvanse Adult, 1) – Elvanse Adult®

• Clinical trials
  • To demonstrate the additional benefit of lisdexamfetamine dimesilate compared with the appropriate comparator therapy, the pharmaceutical manufacturer submitted five RCTs.
  • Using a placebo as a bridge comparator, lisdexamfetamine was compared with atomoxetine (SPD489-403 and NCT00510276) and with methylphenidate (NRP104303 and NCT01259492) were compared with one another.
  • A study with a crossover design (SP489-316) was not used for indirect comparison, as no suitable study with the appropriate comparator therapy was identified.

a) Adults with attention-deficit/hyperactivity disorder (ADHD) present since childhood of at least moderate severity (at least moderate functional impairment in two or more situations, affecting several aspects of life), who have already received drug therapy

• An additional benefit is not proven.
• The studies submitted are not suitable for establishing any additional benefit of lisdexamfetamine dimesilate compared with the appropriate comparator therapy, as there was insufficient documentation to show that the prior treatment formed part of a comprehensive therapeutic plan, nor did the studies ensure this.
• It cannot therefore be assumed that the drug is being used in accordance with the marketing authorisation.
• Furthermore, the study duration was too short to allow for a benefit assessment in the context of a chronic condition.
• Overall, therefore, for patient population a), an additional benefit is not proven.

b) Adults with attention-deficit/hyperactivity disorder (ADHD) present since childhood of at least moderate severity (at least moderate functional impairment in two or more situations and affecting several aspects of life), who have not previously received drug treatment

• The additional benefit is not proven.
• On balance, therefore, an additional benefit is not proven for patient population b).

Courtesy translation only, please refer to the German original.