Contact: Robert Jaffe PondelWilkinson Inc. (310) 279-5980
LANNETT REACHES SPECIAL PROTOCOL ASSESSMENT AGREEMENT WITH FDA FOR COCAINE HCl PHASE III TRIAL
Philadelphia, PA - January 4, 2012 - Lannett Company, Inc.
(NYSE AMEX: LCI) today announced that it has reached
agreement with the U.S. Food and Drug Administration (FDA) on
a Special Protocol Assessment (SPA), 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.
"The SPA agreement provides a clear registration pathway for
our C-Topical product, and demonstrates exemplary
collaboration and cooperation between the FDA and Lannett,"
said Arthur P. Bedrosian, president and chief executive
officer of Lannett. "We expect the clinical trial to be
completed, and to file a related 505(b)(2) New Drug
Application (NDA) in 2012. With this milestone, we can now
look forward to realizing the first of many future benefits
of our newly-formed clinical trial operations group within
Lannett."
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of 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 statements, including, but not limited to, completing the Phase III trial and
filing a related 505(b)(2) New Drug Application (NDA) in 2012, whether expressed or implied, are 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 difficulty in predicting the timing or outcome of FDA or
other regulatory approvals or actions, the ability to successfully commercialize products upon approval,
Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time. 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.
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