11 June 2021
Adalvo is delighted to announce the successful Pivotal BE outcome of its Lisdexamfetamine hard capsules development which demonstrates Adalvo´s ability to continuously offer first-to-market opportunities to its valued partners.
Our fasting Pivotal BE studies were carried out on Lisdexamfetamine hard capsules 70mg (Adalvo) and Elvanse® hard capsules 70mg (Shire). Given the successful results Adalvo is aiming to be in the first wave of filing in all key markets and aims to make the product available for our patients and partners as soon as intellectual protection on the product expires. The successful bioequivalence results further pave the road to our selected and boutique portfolio, consisting of complex products, including the central nervous system therapeutic domain, in which Adalvo has a number of interesting products.
Adalvo is targeting a generic and bioequivalent version of Elvanse® tablets that has been developed in close co-operation with one of our Alvogen affiliates. Elvanse® is a CNS drug originally developed by Shire 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.
In addition to our generic version of the capsules, Adalvo is also pursuing an enhanced version of Lisdexamfetamine that will come in the form of a ready-to-use oral solution. We are the only known company who is targeting child-friendly version of this product which will dramatically increase the patient value
Disclaimer: Lisdexamfetamine capsules which are subject to patent protection are currently not offered or made available in countries where patents are in force.