Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fesoterodine · 17 trials · 11 indications
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 is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
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.
Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses \[measured in log10 milliseconds (MS)\]. Lower scores meant a better performance.
Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses \[measured in log10 milliseconds (MS)\]. Lower scores meant a better performance.
| Arm | Type | Description |
|---|---|---|
| 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 | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | 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. |
| 4mg fesoterodine | EXPERIMENTAL | - |
| fesoterodine 8mg | EXPERIMENTAL | - |
| 1mg alprazolam | ACTIVE_COMPARATOR | - |
| 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 |
|---|---|---|
| fesoterodine fumarate | DRUG | 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks |
| Fesoterodine | DRUG | Fesoterodine 4mg or 8mg |
| Placebo | DRUG | Placebo |
| tolterodine tartrate | DRUG | 4 mg once daily (OD) for 12 weeks |
| Fesoterodine ER (fasted) | DRUG | Commercial Fesoterodine ER 4 mg (single dose) |
| Fesoterodine SR3 (fasted) | DRUG | Fesoterodine SR3 4 mg (single dose) |
| Fesoterodine SR3 (fed) | DRUG | Fesoterodine SR3 4 mg (single dose) with high-fat meal |
| Fesoterodine ER (fed) | DRUG | Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal |
| Fesoterodine SR3 (sprinkle) | DRUG | Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce |
| Fesoterodine SR4 (fasted) | DRUG | Fesoterodine SR4 4 mg (single dose) |
| Fesoterodine SR4 (fed) | DRUG | Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal |
| Fesoterodine SR4 (sprinkle) | DRUG | Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce |
| 4mg fesoterodine | DRUG | 4mg tablet once daily for 6 days |
| 8mg fesoterodine | DRUG | 4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days |
| alprazolam 1mg | DRUG | 1mg tablet once on last day of treatment period at clinic |
| 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 OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day. Exclusion Criteria: * Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excip...
Fesoterodine is used for the treatment of overactive bladder with symptoms of frequency, urgency, and urge urinary incontinence. It is also studied for overactive bladder syndrome and therapeutic equivalency. The drug is being developed as a small molecule therapy for these urological conditions.
Fesoterodine is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's efficacy and safety for overactive bladder indications.
Fesoterodine is in Phase 3 clinical development for overactive bladder. It has completed multiple Phase 3 trials, including studies assessing treatment satisfaction and symptom improvement, as well as long-term safety and efficacy. The drug remains investigational and is not yet approved.
Fesoterodine has been studied in several completed clinical trials. NCT00425100 is a Phase 3 trial in overactive bladder patients with 516 participants. NCT00561951 is a Phase 2 dose-finding study with 951 participants. NCT00658684 is a long-term Phase 3 safety study with 153 participants. NCT00857896 is a Phase 2 pediatric trial with 21 participants.
Fesoterodine is an antimuscarinic agent that works by blocking muscarinic receptors in the bladder, which helps reduce bladder muscle contractions. This mechanism is intended to alleviate symptoms of overactive bladder, including urinary frequency, urgency, and urge incontinence.
Fesoterodine is a distinct medication from other overactive bladder treatments. It is a small molecule developed by Pfizer, and its clinical trials are separate from those of other drugs. No alternative names for Fesoterodine have been established in the clinical trial data.