A Phase III Investigation of Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia for Diagnostic Procedures and Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities.

Trial Profile

A Phase III Investigation of Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia for Diagnostic Procedures and Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2017

At a glance

  • Drugs Cocaine (Primary)
  • Indications Procedural pain
  • Focus Therapeutic Use
  • Sponsors Lannett
  • Most Recent Events

    • 25 Sep 2017 According to a Lannett media release, the comapny has filled a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Cocaine Hydrochloride (HCl) Topical Solution with a proposed indication for the introduction of local (topical) anesthesia for diagnostic procedures and surgeries on or through the accessible mucous membranes of the nasal cavities.
    • 22 Oct 2013 Planned initiation date changed from 1 Jan 2013 to 1 Feb 2014 as reported by ClinicalTrials.gov.
    • 22 Oct 2013 Planned End Date changed from 1 Dec 2013 to 1 Dec 2014 as reported by ClinicalTrials.gov.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top