King Pharmaceuticals Initiates Phase II Clinical Trial Evaluating T-62 As A Treatment For Neuropathic Pain

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials
Article Date: 31 Dec 2008 - 0:00 PDT

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King Pharmaceuticals, Inc. (NYSE: KG) today announced that it has initiated the Phase II clinical trial program evaluating the efficacy and safety of T-62, an oral tablet formulation, the Company's investigational drug for the treatment of neuropathic pain.

Dr. Eric Carter, Chief Science Officer of King, stated, "T-62, a new chemical entity, is an adenosine A1 allosteric enhancer that increases the effectiveness of the body's endogenous adenosine to treat neuropathic pain. The successful development of this product would address a substantial unmet medical need for more effective medicines to treat this serious condition."

The Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia and its associated pain. The study is expected to enroll approximately 130 patients in up to 20 study centers and will evaluate two doses of T-62 and placebo utilizing a parallel design. Each patient will complete a 7-day screening period, a 28-day treatment period, and a 14-day post-treatment period.

About King Pharmaceuticals

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company's focus in specialty-driven markets, particularly neuroscience, hospital and acute care. King strives to be a leader and partner of choice in bringing innovative, clinically-differentiated medicines and technologies to market. http://www.kingpharm.com

About Forward-looking Statements

This release contains forward-looking statements which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the T-62 clinical trial program and the drug's potential benefit. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include dependence on the actual results of the clinical trial program evaluating T-62, including the results of the Phase II clinical trials and any subsequent clinical trials; and dependence on the unpredictability of the duration and results of the U.S. Food and Drug Administration's review of any New Drug Application relating to T-62. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ended September 30, 2008, which are on file with the U.S. Securities and Exchange Commission. King does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.