Tokyo-based Astellas Pharma’s European subsidiary has announced that it has received marketing authorization from the Netherlands Medicines Evaluation Board (MEB) for Vesomni.
The marketing authorization received for Vesomni is related to the "treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy."
A film-coated, bi-layered modified release tablet, Vesomni's key ingredients of the tablet include 6mg of antimuscarinic solifenacin and 0.4mg of the alpha1-adrenoceptor antagonist (a1-blocker) tamsulosin (TOCAS).
Vesomni offers significant improvements when compared to TOCAS on the basis of storage parameters and quality of life in men with moderate to severe storage symptoms and voiding symptoms aged 45 years and over, according to the Phase III data.
Additionally, Vesomni showed improvements compared to placebo over all key endpoints.
The observation in Phase III trials showed that adverse effects like dry mouth and constipation occurred most frequently, but were mild in nature.
