30 October 2020
Adalvo is happy to announce that in addition to our earlier reported studies we successfully closed our last bioequivalence trial that was conducted in steady state dosing. As with our previous studies our trial was carried out on Solifenacin+Tamsulosin modified-release tablets 6mg/0.4mg (Adalvo) and Vesomni® modified-release tablets (Astellas) and our endpoints perfectly matched necessary BE parameters.
Having our last study completed we now have all the clinical trials behind to progress into compilation of our dossier and file at the earliest possible slot. We believe having all studies in place grants Adalvo the position to be among first wave of filers and submit our dossier in all major markets as soon as exclusivity expires.
Disclaimer: Solifenacin+Tamsulosin which is subject to patent protection is currently not offered or made available in countries where patents are in force.