Adalvo announces successful dual pivotal BE trial outcome of Solifenacin + Tamsulosin development

21 July 2020

Adalvo is delighted to announce successful Fed and Fast Pivotal BE outcome of its Solifenacin + Tamsulosin development which demonstrates Adalvo´s ability to continuously offer first-to-market opportunities to its valued partners.

The fixed-dose combination Pivotal BE studies were carried out on Solifenacin+Tamsulosin modified-release tablets 6mg/0.4mg (Adalvo) and Vesomni® modified-release tablets (Astellas). Given the successful results Adalvo is aiming to be in the first wave of filing in all key markets and make the product available for our patients and partners as soon as exclusivity on the product expires. The successful bioequivalence results further pave the road to our selected and boutique portfolio consisting complex products including the urology therapeutical domain in which Adalvo has another six interesting products.

Adalvo is targeting a generic and bioequivalent version of Vesomni® tablets that has been developed on close co-operation with one of our strategic partner. Vesomni® is a specialty urology drug originally developed by Astellas that is indicated for the treatment of benign prostatic hyperplasia.

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Disclaimer: Solifenacin+Tamsulosin which is subject to patent protection is currently not offered or made available in countries where patents are in force.