Urizia (6 mg solifenacin/0.4 mg tamsulosin)
Urizia combines two well-known drugs with different mechanisms of action: Solifenacin (muscarinic receptor antagonist, antimuscarinic agents) and tamsulosin (α1-adreno receptor blocking agent, α-blocker). Urizia is indicated for the alleviation of moderate to severe lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH).
Contrary to α-reductase inhibitors, Urizia only relieves symptoms and does not reduce the prostate volume in patients with enlarged prostate. Combination therapy complicates dose titration in relation to the individual patient and may mean that the patient is exposed to a drug that does not contribute favourably to treatment. In addition, the adverse events from the individual substances are additive.
The treatment price of Urizia is substantially higher than the price of tamsulosin alone as well as of individual combination therapy with tamsulosin and an antimuscarinic agent.
It is IRF’s overall assessment that Urizia should not be used in the treatment of BPH. The addition of an antimuscarinic agent may be considered when treating patients with uncomplicated BPH with distinct storage symptoms if adequate relief of symptoms in monotherapy with an α-blocker has not been achieved, and where treatment with an α-reductase inhibitor is not indicated. However, the additive effect is modest. IRF assesses that it may be advantageous to use α-blockers, such as tamsulosin plus single antimuscarinic agents, as long as the treatment price is taken into account when choosing the appropriate drug.
Urizia was marketed on 6 January 2014 and general reimbursement is granted.