Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies

Abstract

Figure MCC of patients aged 6 monthse<5 years and 5e<18 years at baseline and week 24 (primary endpoint) and week 52 (secondary endpoint; full analysis set). Efficacy and safety of solifenacin in pediatric patients 180.e2

Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity

“…Solifenacin in children and adolescents with overactive bladder: results of a phase 3 randomised clinical trial, 483‐90, Copyright (2017), with permission from Elsevier 26 . Figure 1B and Cadapted from Franco, et al 30 . a Every 3 weeks, dose modification of trial drug could be performed to obtain doses of PED2.5, PED5, PED7.5, or PED10.…”

“…Three subsequent phase III clinical trials, which included PK assessments, have investigated the administration of multiple doses of oral solifenacin succinate suspension to pediatric patients with OAB or NDO. The efficacy and safety results from these trials are briefly mentioned above and have been previously reported 26,30 . The objective of the present investigation was to utilize the data from these trials to characterize the PK of solifenacin through the use of nonlinear mixed effects modeling.…”

“…28,29 Furthermore, two phase III open-label trials in 99 pediatric patients with NDO showed that the use of solifenacin significantly increased maximum cystometric capacity and the antimuscarinic was well tolerated, with most adverse events being mild or moderate in severity. 30 The results of these trials contributed to the European and US approval of oral solifenacin suspension for the treatment of pediatric patients (2-<18 years) with NDO. 31,32 Ascertaining the pharmacokinetics (PK) of potential drugs provides vital information that can be used to determine the optimal dosing regimen to be included in the drug label that informs prescribers.…”

“…The efficacy and safety results from these trials are briefly mentioned above and have been previously reported. 26,30 The objective of the present investigation was to utilize the data from these trials to characterize the PK of solifenacin through the use of nonlinear mixed effects modeling.…”

“…No unexpected safety concerns were apparent when solifenacin suspension was administered to children and adolescents with NDO and the drug appeared to be an efficacious and well‐tolerated treatment, with a minority of patients reporting adverse events, when it was used to treat children with oxybutynin‐ or tolterodine‐refractory NDO 28,29 . Furthermore, two phase III open‐label trials in 99 pediatric patients with NDO showed that the use of solifenacin significantly increased maximum cystometric capacity and the antimuscarinic was well tolerated, with most adverse events being mild or moderate in severity 30 . The results of these trials contributed to the European and US approval of oral solifenacin suspension for the treatment of pediatric patients (2–<18 years) with NDO 31,32…”