Lannett Company, Inc. 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.
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.
Robert Jaffe Co., LLC
Source : prnewswire.com