Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Toviaz is indicated for the treatment of: • Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. FDA label
Also known as fesoterodine fumarate, Toviaz
fesoterodine · 15 trials · 10 indications
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| Fesoterodine fumarate | EXPERIMENTAL | - |
| Fesoterodine 4mg or 8mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Fesoterodine (Double-Blind) | EXPERIMENTAL | - |
| Placebo (Double-Blind) | PLACEBO_COMPARATOR | - |
| Fesoterodine | EXPERIMENTAL | Tablets |
| Tolterodine | ACTIVE_COMPARATOR | Capsules |
| Open Label-fesoterodine | EXPERIMENTAL | Single treatment study arm. |
| Fesoterodine once daily | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Fesoterodine fumarate 4 mg (Double-Blind) | EXPERIMENTAL | - |
| Fesoterodine fumarate 8 mg (Double-Blind) | EXPERIMENTAL | - |
| Treatment A, Cohort 1 | EXPERIMENTAL | - |
| Treatment B, Cohort 2 | EXPERIMENTAL | - |
| Treatment C, Cohort 1 | EXPERIMENTAL | - |
| Treatment D, Cohort 2 | EXPERIMENTAL | - |
| Treatment E, Cohort 1 and/or Cohort 2 | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | 4 mg fesoterodine IR beads in capsule under fasting condition |
| B | EXPERIMENTAL | 4 mg fesoterodine 10% coated ER beads in capsule under fasting condition |
| C | EXPERIMENTAL | 4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. |
| D | EXPERIMENTAL | 4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. |
| E | EXPERIMENTAL | 4 mg fesoterodine ER tablets under fasting condition. |
| F | EXPERIMENTAL | 4 mg fesoterodine TBD % coated ER beads in capsule under fed condition. |
| Reference | OTHER | a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Zwickau |
| Test | OTHER | a single dose of 8 mg fesoterodine (Toviaz™ 8 mg) tablet manufactured at Vega Baja (Test) |
| Fesoterodine Alone | EXPERIMENTAL | Reference treatment |
| fesoterodine plus fluconazole | OTHER | Test treatment |
| A (Cohort I) | EXPERIMENTAL | - |
| B (Cohort I) | EXPERIMENTAL | - |
| C (Cohort I) | EXPERIMENTAL | - |
| B (Cohort II) | EXPERIMENTAL | - |
| D (Cohort II) | EXPERIMENTAL | - |
| E (Cohort II) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tolterodine ER | DRUG | The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks. |
| Placebo | DRUG | Placebo treatment will be once daily(QD) for 12 weeks. |
| Fesoterodine | DRUG | The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks. |
| fesoterodine fumarate | DRUG | 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks |
| tolterodine tartrate | DRUG | 4 mg once daily (OD) for 12 weeks |
| fesoterodine plus fluconazole | DRUG | On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1) |
Inclusion Criteria: * Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit. * Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit * Mea...
Fesoterodine is used to treat overactive bladder, including symptoms of frequency, urgency, and urge urinary incontinence. It has also been studied in overactive bladder syndrome and stress urinary incontinence. It is a small molecule therapeutic in the nephrology area.
Fesoterodine targets CHRM2 and CHRM3, which are muscarinic acetylcholine receptors. It acts as an antagonist at these receptors, blocking their activity. This mechanism is intended to reduce bladder contractions associated with overactive bladder symptoms.
Fesoterodine is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for its clinical development and regulatory submissions.
Fesoterodine is in Phase 3 of clinical development. It is an investigational drug and has not been approved by the FDA for the studied indications. The development program includes completed Phase 1 and Phase 2 trials.
Fesoterodine has been evaluated in several completed trials, including NCT01566760, which studied food effects on fesoterodine fumarate and the pharmacokinetics of 5-hydroxymethyl tolterodine; NCT01286454, a bioavailability and food effect study; NCT01042236, a Phase 2 trial in stress urinary incontinence; and NCT00911235, which examined the effect of fluconazole on fesoterodine pharmacokinetics.
Yes, fesoterodine fumarate is the fumarate salt form of fesoterodine. Other names include 4mg fesoterodine and Fesoterodine ER (fasted), which refer to specific dosage strengths or administration conditions. All refer to the same active drug.