• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Vesicare, VESIcare LS (solifenacin succinate)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Vesicare, VESIcare LS (solifenacin succinate)

  • Profile

Profile

Contact Information

Contact: Astellas Pharma
Website: http://www.vesicare.com/

Currently Enrolling Trials

    Show More

    General Information

    Vesicare/VESIcare LS contains solifenacin, a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle. Antagonism at these receptors has been shown to reduce tonus (elastic tension) of the urinary bladder and slow parasympathetic contractions.

    Vesicare is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

    VESIcare LS is specifically indicated for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages 2 years of age and older.

     

    Mechanism of Action

    Solifenacin acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

    Side Effects

    Adverse events associated with the use of Vesicare may include, but are not limited to, the following:

    • Dry mouth
    • Constipation
    • Blurred vision
    • Urinary retention
    • Dry eyes

    In addition, three serious intestinal complications (one fecal impaction, one colonic obstruction and one intestinal obstruction) and one case of angioneurotic edema occurred among patients taking Vesicare in clinical trials. There was not a significant difference in the incidence of serious adverse events between subjects taking the drug for 12 weeks and 12 months.

    Dosing/Administration

    Vesicare is administered via an oral tablet of 5 mg once daily, with a possible increase in dosage, to 10 mg once daily, in subjects experiencing good tolerance. Dosing should occur with liquids, and tablets should not be crushed or broken prior to administration.

    VESIcare LS is supplied as a liquid oral suspension. The recommended starting and maximum VESIcare LS oral suspension doses are weight-based and are administered once daily. After administration of the recommended starting dose, the dose may be increased to the lowest effective dose but should not exceed the maximum recommended dose.

    Clinical Trial Results

    FDA approval of Vesicare was based upon four 12-week multicenter, double-blind, placebo-controlled, parallel-group studies. The studies enrolled 3,027 subjects with at least a three-month history of increased urinary frequency, urinary urgency and/or urge or mixed (predominantly urge) incontinence. Subjects in two of the trials received either 5 or 10 mg Vesicare or placebo once daily, and subjects in the other two received exclusively 10 mg or placebo once daily. All patients completing the 12-week studies were eligible to enter an open label long-term extension. All four trials found that Vesicare offered significantly better efficacy than placebo in both primary (mean change from baseline to 12 weeks in number of micturitions/24 hours) and secondary (including mean change from baseline to 12 weeks in number of incontinence episodes/24 hours, and mean volume voided per micturition) end points.

    The FDA approval of VESIcare LS for use in pediatric patients with NDO was based on two clinical trials with 95 pediatric NDO patients, ages 2 to 17 years old. The studies were designed to measure (as a primary efficacy end point) the maximum amount of urine the bladder could hold after 24 weeks of treatment. In the first study, 17 patients ages 2 to younger than 5 years old were able to hold an average of 39 mL more urine than when the study began. In the second study, 49 patients ages 5 to 17 years were able to hold an average of 57 mL more urine than when the study began. Reductions in spontaneous bladder contractions, bladder pressure and number of incontinence episodes were also observed in both studies.

     

     

     

     

    Approval Date: 2004-11-01
    Company Name: Astellas
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing