Adalvo announces successful pivotal BE outcome for Vortioxetine Film-Coated Tablets

05 January 2022

We would like to take this opportunity to wish you a Happy New Year! We hope that 2022 comes bearing great opportunities and achievements.

As this new year begins, Adalvo is delighted to announce that we have successfully completed our Pivotal BE study of Vortioxetine Film-Coated Tablets.

Our product has been developed based on the reference brand Brintellix 20mg which is indicated for the treatment of Anti-Depression and sold at around $1.5bn in 2020, according to IQVIA.

This product is being developed as part of a strategic collaboration with one of our partners. We are now moving ahead into dossier completion, and will proceed with DCP submission, which is scheduled for Q2 2022.

Based on our positive results, we expect to be amongst the first-to-file / first-to-market companies in all our major markets.