Fesoterodine (Toviaz) Toviaz | European Medicines Agency (EMA)Skip to main contentSearchMain navigation * Medicines * Find medicine * Therapeutic areas: latest updates * Download medicine data * What we publish on medicines and when * Medicines under evaluation * National registers * Human regulatory * Overview * Research and development * Marketing authorisation * Post-authorisation * Medical is a summary of the European public assessment report (EPAR) for Toviaz. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Toviaz. Expand sectionCollapse sectionWhat is Toviaz?Toviaz is a medicine containing the active substance fesoterodine
A Double-blind, Randomised Four-way Crossover Study to Compare the Effects of Fesoterodine 4 and 8 mg Once Daily and Qxybutynin 5 mg Twice Daily After Steady-state Dosing Versus Placebo on Cognitive Function in Overactive Bladder-wet Patients over the Ag There is a reported association between overactive bladder (OAB) treated with antimuscarinic drugs and an increased risk of a dementia diagnosis, although short-term data suggest that newer OAB antimuscarinics are cognitively safe. This study examined the cognitive safety of fesoterodine in older adults with mild cognitive impairment (MCI) and OAB. This four-way randomised crossover study examined the cognitive effects of fesoterodine 4 and 8 mg and oxybutynin 5 mg b.i.d. compared with placebo. Older adult patients with OAB and MCI were
Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study. Neurogenic detrusor overactivity (NDO) can damage the upper urinary tract leading to chronic renal impairment. Antimuscarinic therapy is used to improve urinary incontinence and protect the upper urinary tract in patients with NDO. This study investigated safety and efficacy of fesoterodine, a muscarinic receptor antagonist, in 6‒<18-year-old patients with NDO (NCT01557244). This open-label phase 3 study included 2 pediatric cohorts. Patients in Cohort 1 (bodyweight >25 kg) were randomized to fesoterodine 4 or 8 mg extended-release tablets or oxybutynin XL tablets administered over the 12-week active comparator-controlled phase. The safety extension phase evaluated
[Efficacy of fesoterodine for prevention of autonomic dysreflexia in patients with neurogenic dysfunction of the bladder after spinal cord injury]. to evaluate the effectiveness of fesoterodine for the prevention of autonomic dysreflexia (AD) in patients with neurogenic bladder dysfunction (NBD) after spinal cord injury (SCI). a total of 53 patients with AD were included in the study . In the main group (n=33) patients received fesoterodine 4 mg per day for 12 weeks as a treatment for neurogenic bladder dysfunction and prevention of AD. In the control group (n=20), patients were monitored for 12 weeks without specific treatment. The assessment was based on the results of ADFSCI and NBSS questionnaires, daily blood pressure monitoring with the completion of a self-observation diary
On-demand use of fesoterodine: a new paradigm for extended release antimuscarinics. We aimed to compare on-demand and continuous use of fesoterodine 4 mg concerning efficacy and adverse effects. A total of 100 patients who were diagnosed with non-neurogenic overactive bladder (OAB) syndrome were included in the study. All patients were evaluated with MMSE, ICIQ-SF, SEAPI quality of health and OAB-V8 questionnaires, at the beginning, 1st month and 4th month. Fesoterodine 4 mg was started for treatment. At the end of the 1st month, patients who obtained benefit from the treatment were 1:1 randomized into two groups. In group 1, fesoterodine 4 mg was given 1 × 1 in a standard manner whereas in group 2 patients took the pills on demand. Both groups were evaluated for efficacy and adverse
Atomoxetine and fesoterodine combination improves obstructive sleep apnoea severity in patients with milder upper airway collapsibility. The combination of the noradrenergic atomoxetine plus the anti-muscarinic oxybutynin acutely increased genioglossus activity and reduced obstructive sleep apnoea (OSA) severity. However, oxybutynin has shorter half-life than atomoxetine and side effects that might discourage long-term usage. Accordingly, we aimed to test the combination of atomoxetine and fesoterodine (Ato-Feso), a newer anti-muscarinic with extended release formulation, on OSA severity and endotypes. Twelve subjects with OSA underwent a randomized, double-blind, crossover trial comparing one night of atomoxetine plus fesoterodine (80-4 mg) to placebo. Parameters of OSA severity (e.g
A randomized, crossover trial comparing the efficacy and safety of fesoterodine and extended-release oxybutynin in children with overactive bladder with 12-month extension on fesoterodine: The FOXY study. We sought to assess and compare safety and efficacy of fesoterodine and oxybutynin extended-release in the treatment of pediatric overactive bladder (OAB). We conducted a non-inferiority , randomized, double-blind, crossover trial comparing fesoterodine 4-8 mg and oxybutynin 10-20 mg once daily (QD) in children with OAB aged 5-14 years (2015-2018). Every child received the first medication for eight weeks, followed by crossover to the second antimuscarinic after a three-days washout. Dose up-titration was possible at mid-course. Patients could enter a fesoterodine 12-month extension
Efficacy of fesoterodine fumarate (8 mg) in neurogenic detrusor overactivity due to spinal cord lesion or multiple sclerosis: A prospective study. Antimuscarinic drugs are the first-line choice in the treatment of patients with neurogenic Detrusor Overactivity (nDO). Fesoterodine fumarate is the newest antimuscarinic drug. Limited data are published about the use of fesoterodine fumarate in patients suffering from neurogenic lower urinary tract dysfunction. Our study aims to determine the efficacy of fesoterodine fumarate on patients with nDO due to spinal cord lesion or multiple sclerosis (MS). This is an open-label prospective interventional study. Eligible patients were 18-80 years old with SCL or MS and nDO confirmed by a urodynamic study (UDS). At baseline, patients underwent a UDS
Fesoterodine An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationNo information is available on the use of fesoterodine during breastfeeding. Long-term use of fesoterodine might reduce milk production or milk letdown. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).Drug LevelsMaternal Levels. Relevant published information was not found as of the revision date.Infant Levels. Relevant
Randomized, controlled trial of fesoterodine fumarate for overactive bladder in Parkinson's disease. To evaluate short-term efficacy and safety of fesoterodine fumarate in Parkinson's disease (PD) patients with overactive bladder (OAB) symptoms. This is a randomized, double-blind, placebo-controlled study. It also has an open-label extension phase. From May 2016 to May 2018, 63 patients were randomized to receive fesoterodine 4 mg or placebo for 4 weeks. At the end of 4 weeks of randomization phase, patients were received fesoterodine fumarate 4 mg daily for another 4 weeks at the open-label extension phase. The change in the mean number of micturition episodes per 24 h period was the primary outcome measure of the study. The number of micturition episodes per 24 h period significantly
Factors contributing to the efficacy of two add-on therapies of fesoterodine or mirabegron to silodosin monotherapy for persistent overactive bladder in men with lower urinary tract symptoms.
Treatment Satisfaction with Flexible-dose Fesoterodine in Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy: A Multicenter Single-Arm Clinical Study. We investigated treatment satisfaction with flexible-dose fesoterodine in patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy. The subjects were prescribed fesoterodine 4 mg for 4 weeks and fesoterodine 4 mg or 8 mg for another 8 weeks. The primary end point of this study was patients' satisfaction after 12 weeks of fesoterodine treatment on a five-point Likert scale. Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final
Do patient characteristics predict which patients with overactive bladder benefit from a higher fesoterodine dose? We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from fesoterodine 8 mg versus 4 mg. In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were
Comparison in the efficacy of fesoterodine or mirabegron add-on therapy to silodosin for patients with benign prostatic hyperplasia complicated by overactive bladder: A randomized, prospective trial using urodynamic studies. To compare the efficacy of fesoterodine or mirabegron add-on therapy for persistent overactive bladder (OAB) symptoms despite silodosin monotherapy in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, in both subjective and objective aspects. A total of 120 patients with persistent OAB symptoms despite silodosin monotherapy were randomized to receive add-on therapy with fesoterodine (4 mg/day) or mirabegron (50 mg/day) for 12 weeks. At week 12, changes from baseline in patients' subjective symptoms and voiding/storage functions, as assessed
[The efficacy of fesoterodine in patients after transurethral resection of the prostate]. For a long time, benign prostatic hyperplasia (BPH) was considered as only cause of lower urinary tract symptoms (LUTS) in elderly men. More than 30% of patients underwent surgery by the age of 80. Unsatisfactory outcome of surgical treatment of BPH are observed in 9-27% of cases. Various irritative frequency, number of urgency episodes, average IPSS and QOL score decreased to an average of 5.7 times a day, 0.4 times, 1.2 times, 9.3 points and 1.6 points, respectively. Average Qmax increased to 15.5 ml/sec. No adverse events were detected. According to the results of our study, the use of m-cholinoblockers, in particular Fesoterodine (Toviaz), in combination with standard therapy in patients
Early Fesoterodine Fumarate Administration Prevents Neurogenic Detrusor Overactivity in a Spinal Cord Transected Rat Model. In spinal cord injury, onset of detrusor overactivity (DO) is detrimental for quality of life (incontinence) and renal risk. Prevention has only been achieved with complex sophisticated electrical neuromodulation techniques. To assess the efficacy of early fesoterodine
Efficacy and safety of fesoterodine treatment for overactive bladder symptoms in elderly women with and without hypertension. To assess fesoterodine treatment in elderly women with overactive bladder with and without hypertension. Data for 2527 elderly women with overactive bladder symptoms, including urgency urinary incontinence, were pooled from 10 double-blind, placebo-controlled fesoterodine at week 12 were observed for fesoterodine treatment versus placebo in women with hypertension and those without (P < 0.05). The diary-dry rate (no urgency urinary incontinence episodes), the proportion with less than eight micturitions/24 h, overactive bladder symptom bother and health-related quality of life were also statistically significantly improved by fesoterodine treatment in both populations
Physiological based pharmacokinetic modeling to estimate in vivo Ki of ketoconazole on renal P-gp using human drug-drug interaction study result of fesoterodine and ketoconazole. This study was conducted to estimate in vivo inhibition constant (Ki) of ketoconazole on renal P-glycoprotein (P-gp) using human drug-drug interaction (DDI) study result of fesoterodine and ketoconazole. Fesoterodine is a prodrug which is extensively hydrolyzed by non-specific esterases to the active metabolite 5-hydroxymethyl tolterodine (5-HMT). 5-HMT is then further metabolized via Cytochrome P450 (CYP) 2D6 and CYP3A4. It is reported that 5-HMT is a substrate of P-gp whereas fesoterodine is not. Renal clearance of 5-HMT is approximately two-times greater than renal glomerular filtration rate. This suggests
Fesoterodine for the Treatment of Nocturnal Urgency in Patients with Overactive Bladder Syndrome: An Analysis of Responders and Non-Responders. A recent study demonstrated improvement in nocturnal urgency in patients with overactive bladder when treated with fesoterodine. In the current study we aimed to determine which bladder diary parameters predict the response to fesoterodine in these patients. Patients with nocturnal urgency completed a 2-week, single-blind placebo run-in followed by 1:1 double-blind randomization to 12 weeks of fesoterodine or placebo. We analyzed bladder diary parameter changes from baseline to week 12, including the actual number of night voids (total number of nocturia episodes), maximum voided volume, nocturnal bladder capacity, Nocturnal Bladder Capacity Index
The Beneficial Effect of Fesoterodine, a Competitive Muscarinic Receptor Antagonist on Erectile Dysfunction in Streptozotocin-Induced Diabetic Rats. To investigate the possible role of fesoterodine (a competitive muscarinic receptor antagonist) on erectile dysfunction in streptozotocin-induced diabetic rats. A total of 16 adult male Sprague-Dawley rats were equally divided into control and diabetic groups. Diabetes was induced by a single intravenous injection of streptozotocin (25-35 mg/kg). In vivo erectile responses were evaluated by the stimulation of cavernosal nerves, and measurements were repeated after the intracavernosal injection of fesoterodine (1 µM) in rats. The relaxation responses to fesoterodine were examined via incubation with various inhibitors. The relaxant responses