Lannett (LCI) Announces Positive Results from C-Topical Phase 3

October 27, 2016 6:51 AM EDT

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Lannett Company, Inc. (NYSE: LCI) announced successful results from a placebo-controlled Phase III clinical study evaluating C-Topical (cocaine hydrochloride solution) 4% and 10% as a local anesthetic for diagnostic procedures or surgeries on or through the inside of the nose.

The 646-patient study met all primary clinical endpoints of the trial and had a statistically significant treatment effect for both the 4% and the 10% solutions. Toxicology and pharmacokinetic studies are ongoing and expected to be completed by year end.

"We are very pleased by the positive Phase III results for C-Topical," said Arthur Bedrosian, chief executive officer of Lannett. "Upon the successful completion of the toxicology and pharmacokinetic studies for C-Topical, our plan is to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) during the summer of 2017. The success of C-Topical as a local anesthetic solution suggests that it could become an important option for use by otolaryngologists (ear, nose and throat) physicians and specialists for office-based and in-patient procedures."

C-Topical is administered by means of cotton applicators, called pledgets.

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