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.
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
- 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.