LANNETT ANNOUNCES SUCCESSFUL PHASE III CLINICAL TRIAL RESULTS FOR PROPRIETARY C-TOPICAL® PRODUCT
PHILADELPHIA, Oct. 27, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today 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. The most common treatment-related adverse events were mild reversible hypertension or tachycardia. 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 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 findings of this Phase III C-Topical study suggest C-Topical could become an important topical anesthetic option for use by otolaryngologists (ear, nose and throat) physicians and specialists for appropriate office-based and in-patient procedures.”
About Phase III C-TOPICAL trial:
Randomized, prospective, multi-center, double blind placebo-controlled parallel group study of a Placebo Topical Solution vs. Cocaine HCl 4% Topical Solution for safety and efficacy, and Cocaine HCl 4% and 10% Topical Solution for Safety as an anesthetic prior to a diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities in 646 patients. The primary endpoint for this trial is anesthesia success immediately after application of study drug and sustained throughout the diagnostic procedure or surgery.
C-Topical is a pre-1938 local anesthetic drug product, which is undergoing study for approval under a New Drug Application. C-Topical is being investigated for administration by means of cotton applicators, called pledgets to the accessible mucous membranes of the oral, laryngeal and nasal cavities.
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company’s website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, the company’s ongoing development of C-Topical; interpretation of the data and results from the Phase 3 clinical trial; plans for, and the expected timing of, the C-Topical NDA submission with the FDA; plans to develop and commercialize C-Topcial and its market potential; and, the potential therapeutic and other benefits of C-Topcial, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company’s Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.