En urology, VECALMYS 6 mg/0.4 mg modified release tablet is a new specialty indicated in the treatment of moderate to severe symptoms of filling (urinary urgency [urgence]urinary frequency) and emptying symptoms linked to benign prostatic hyperplasia (BPH) in men responding inadequately to monotherapy (cf. VIDAL Reco “Benign prostatic hypertrophy”).
VECALMYS is the first specialty combining solifenacin (6 mg) and tamsulosin (0.4 mg):
- solifenacin (VESICARE and generics) is a competitive and selective antagonist of muscarinic receptors;
- tamsulosin is a blocking alpha (alpha1-adrenergic receptor antagonist) included in the composition of the specialties OMIX, OMEXEL, COMBODART (in combination with dutasteride) and generics.
In its opinion of November 8, 2023, the Transparency Commission (CT) indicated that VECALMYS is a second-line treatment, which can be offered as an alternative to taking these two active ingredients separately. [1].
Demonstrated effectiveness versus tamsulosin alone
The effectiveness of the fixed combination solifenacin/tamsulosin (VECALMYS) was demonstrated compared to tamsulosin alone in the NEPTUNE study [2] performed in 1,334 patients with moderate to severe filling symptoms and urination-related symptoms, after 12 weeks of treatment. The primary endpoints were the change in IPSS score (International Prostate Symptom Score) and TUFS score (Total Urgency Urgency and Frequency Score). The NEPTUNE II extension study shows that the effect of VECALMYS is maintained.
On the basis of this study, the CT attributed a moderate actual benefit (SMR) to VECALMYS [1]. She notes « limited scope of results » with a « quantity of effect observed small and established in the short term » compared to tamsulosin monotherapy. It also highlights the absence of comparison of solifenacin/tamsulosin dual therapy to solifenacin alone.
The CT considers that VECALMYS does not provide any improvement in actual benefit (ASMR) in the current therapeutic strategy in failure of monotherapy compared to taking the different components of the fixed combination separately.
VECALMYS in practice
The dosage is 1 VECALMYS tablet once a day orally, with or without food. This dose corresponds to the maximum daily dosage.
The tablet should be swallowed whole and without being chewed or chewed. It should not be crushed.
Administrative identity
List I
Box of 30, CIP 3400930259092
Refundable at 30% [3]
Prix public TTC = 10.83 euros TTC [4]
Approval for communities [5]
Besins Healthcare France Laboratory
