We use cookies to provide you with a better experience. By clicking the Accept button, you are agreeing to our use of cookies in accordance with our Privacy Policy.
  • Patient Resources
    • 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
    • Glossary
  • Professional Resources
    • Research Center Profiles
    • Industry Provider Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
  • About Us
  • Contact Us
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Otiprio (ciprofloxacin otic suspension)

  • 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

Otiprio (ciprofloxacin otic suspension)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Otiprio is an oral suspension of ciprofloxacin, a fluoroquinolone antibacterial.

    Otiprio is specifically indicated as a single dose treatment for pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

    Otiprio is supplied as a suspension for intratympanic administration. The recommended dose is a single intratympanic administration of one 0.1 mL (6 mg) dose into each affected ear, following suctioning of middle ear effusion.

    Clinical Results

    FDA Approval

    The FDA approval of Otiprio was based on two phase III randomized, multicenter, controlled clinical trials in 532 pediatric patients with bilateral otitis media with effusion undergoing myringotomy with tympanostomy tube placement. The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up. Data showed a single intraoperative administration of Otiprio demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).

    Side Effects

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

    • nasopharyngitis
    • irritability

    Mechanism of Action

    Otiprio is an oral suspension of ciprofloxacin, a fluoroquinolone antibacterial. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA. 

    Additional Information

    For additional information regarding Otiprio or bilateral otitis media with effusion in pediatrics undergoing tympanostomy tube placement, please visit http://otiprio.com/

    Approval Date: 2015-12-01
    Date Created: 2015-12-14 12:42:49
    Company Name: Otonomy
    Back to Listings

    Upcoming Events

    • 16Dec

      Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

    Featured Products

    • Regenerative-medicine-steps-to-accelerate-development-pdf

      Regenerative Medicine: Steps to Accelerate Development — PDF

    • Clinical-trial-agreements-a-guide-to-key-words-and-phrases-pdf

      Clinical Trial Agreements: A Guide to Key Words and Phrases — PDF

    Featured Stories

    • Ich_logo

      ICH Overhauls 22-Year-Old Clinical Studies Guideline

    • Survey_chart2019

      Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed

    • China-360x240

      U.S. Tops List of Trial Startups With China Making Progress in Phase 1

    • Phoneapp-360x240

      Device Apps Present Unique Risks in Trials

    New!

    2019 Site Survey Reports

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy

    Footer Logo

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

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing