We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » INSPIRE TO BEGIN TESTING OF INTRANASAL EPINASTINE

INSPIRE TO BEGIN TESTING OF INTRANASAL EPINASTINE

May 31, 2006

Inspire Pharmaceuticals has announced today plans to file an investigational new drug (IND) application and begin Phase II clinical testing of intranasal epinastine for the treatment of seasonal allergic rhinitis, following the recent completion of a pre-IND meeting with the FDA.

The company expects to submit the IND application for intranasal epinastine in the third quarter of 2006 and begin clinical testing by year-end 2006. The Phase II program will include clinical and toxicology studies to determine the optimal formulation and dose. The primary Phase II trial is expected to be a 14-day dose-ranging trial in 600 to 700 subjects with seasonal allergies.

KEYWORDS Drug Pipeline Alert

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

  • 11Oct

    1st Annual Quality Management vSummit

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • AngioDynamics Gets Expanded Clearance for Auryon Atherectomy System

  • Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

  • FDA Issues Update on Becton Dickinson’s Recall

  • FDA Grants Accelerated Approval to Enhertu for HER2-Mutant NSCLC

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

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