Adalvo announces successful Pivotal BE outcome of Lisdexamfetamine Oral Solution 10mg / ml

26 August 2021

Adalvo is delighted to announce the successful Pivotal BE outcome of its Lisdexamfetamine Oral Solution 10mg / ml which has been developed in close collaboration with Laboserve & Pharma-Data. We are now moving ahead into regulatory submission, whereby a DCP slot has already been granted.

This value-added version of Lisdexamfetamine comes in the form of a taste-masked, ready-to-use oral solution. Our product is a child-friendly, re-purposed version of Elvanse®, a CNS drug that is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The brand (together with its US sister-brand that is called Vyvanse®) currently sells over $4 billion across the globe. Beyond patient compliance our product is also patent protected both in EU and US.

We are the only known company who is targeting a differentiated child-friendly version of this product which will dramatically increase the patient value and demonstrates our ability to continuously offer highly differentiated, value-added products to our partners.