Lannett Reaches Special Protocol Assessment Agreement with FDA for Cocaine HCl Phase III Trial

Lannett Company, Inc.

today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (

), regarding the design of a Phase III study of the company's Cocaine HCl topical solution product, C-Topical^. The Phase III trial will be a randomized, prospective, multi-site, double-blind, placebo-controlled, parallel-group study of C-Topical^ Solution as an anesthetic prior to a diagnostic procedure or surgery. The primary endpoint for the trial is analgesic success immediately after application and sustained throughout the diagnostic procedure or surgery. The study will enroll at least 500 subjects.