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news.Lannett Company has reached an agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA), on the design of a Phase III study of Cocaine HCl topical solution product, C-Topical.
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According to the company, 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.
Lannett president and CEO Arthur P Bedrosian said the SPA agreement provides a registration pathway for C-Topical product, and demonstrates collaboration between the FDA and Lannett.
"We expect the clinical trial to be completed, and to file a related 505(b)(2) New Drug Application (NDA) in 2012," Bedrosian added.