• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA approves OTC Oxytrol for Women for overactive bladder

FDA approves OTC Oxytrol for Women for overactive bladder

January 28, 2013
CenterWatch Staff

The FDA has approved Merck’s Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older. Oxytrol will remain available for men with overactive bladder by prescription only.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include urinary incontinence, feeling the sudden and urgent need to urinate and frequent urination. Overactive bladder affects an estimated 33 million Americans, the majority of whom are older women.

Oxytrol for Women is a patch that is applied to the skin every four days. The patch delivers 3.9mg of oxybutynin per day, which helps relax the bladder muscle. Oxybutynin belongs to a class of drugs known as anticholinergics. It is the first drug in this class to be made available over-the-counter for treatment of overactive bladder.

 “Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder,” said Shaw Chen, M.D., Ph.D., deputy director of the office of drug evaluation IV in the FDA’s Center for Drug Evaluation and Research. “Women should make sure to follow the drug facts label and consult their doctor if their condition does not improve.”

Oxytrol for Women’s safety and effectiveness for over-the-counter use were established in more than 5,000 subjects participating in nine studies. Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately.

Side effects reported during clinical studies were mild and included skin irritation where the patch was applied, dry mouth and constipation. A leaflet with tips to help manage overactive bladder will be provided with the product.

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

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

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    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 or Share My Data

    Footer Logo

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

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing