Adalvo announces positive results from its pivotal fed study for the fixed-dose combination (FDC) of Mirabegron and Solifenacin, marking a step forward in the development of this complex product for the treatment of overactive bladder (OAB).
Why This Matters:
- Mirabegron/Solifenacin is a difficult-to-develop formulation combining two well-established therapies into a single tablet, a first-in-class option in a high-value therapeutic area where no FDC currently exists. The product addresses urgency, increased micturition frequency, and urgency incontinence to improve patient convenience and adherence.
- Mirabegron/Solifenacin FDC is supported by pivotal studies such as SYNERGY I* and SYNERGY II*, which confirmed the efficacy and safety of the co-prescription approach. Mirabegron and Solifenacin are already frequently co-prescribed in key European markets such as Germany and the United Kingdom (IQVIA).
- Combined global sales for Mirabegron and Solifenacin reached $3.7 billion in 2024 (IQVIA), with no competition expected in major regions. The fed study supports progress toward regulatory submission and Day-1 launches in key markets following patent expiries.
Adalvo continues to invest in differentiated urology assets that balance regulatory clarity, medical relevance, and commercial potential.
To explore licensing or partnership opportunities for the Mirabegron/Solifenacin FDC, contact the team today.
*Phase 3 clinical studies sponsored by Astellas Pharma Europe B.V.