Mon Sep 29, 2014 7:45am EDT
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<span id="midArticle_0"/>Sept 29 (Reuters) - Tonix Pharmaceuticals Holding Corp said its lead pain drug failed the main goal of a mid-stage study, sending its shares down by nearly half in premarket trading.
<span id="midArticle_1"/>The drug, TNX-102, is being tested to treat fibromyalgia, a chronic syndrome characterized by widespread pain and lack of sleep.
<span id="midArticle_2"/>The treatment failed the main goal of reducing pain experienced by patients by the 12th week of the trial, Tonix said.
<span id="midArticle_3"/>However, TNX-102 was shown to improve sleep quality in patients, while some subjects experienced a 30 percent reduction in pain, the company added.
<span id="midArticle_4"/>The trial was evaluating the effectiveness and safety of the drug against a placebo in 205 patients.
<span id="midArticle_5"/>Tonix said it plans to discuss the trial results and the design for a late-stage trial with the U.S. Food and Drug Administration.
<span id="midArticle_6"/>The company said that despite failing the main goal of the study, data on TNX-102 would support late-stage clinical trials.
<span id="midArticle_7"/>Fibromyalgia is said to be associated with an imbalance of certain chemicals in the brain.
<span id="midArticle_8"/>According to the National Fibromyalgia Association, 3-6 percent of the world's population suffers from fibromyalgia syndrome.
<span id="midArticle_9"/>Tonix shares were trading down about 50 percent $7.00 in premarket trading on the Nasdaq. The stock closed at $13.96 on Friday. (Reporting By Amrutha Penumudi in Bangalore; Editing by Simon Jennings)
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<span id="articleText"/>(Adds detail, background, shares)
<span id="midArticle_0"/>Sept 29 (Reuters) - Tonix Pharmaceuticals Holding Corp said its lead pain drug failed the main goal of a mid-stage study, sending its shares down by nearly half in premarket trading.
<span id="midArticle_1"/>The drug, TNX-102, is being tested to treat fibromyalgia, a chronic syndrome characterized by widespread pain and lack of sleep.
<span id="midArticle_2"/>The treatment failed the main goal of reducing pain experienced by patients by the 12th week of the trial, Tonix said.
<span id="midArticle_3"/>However, TNX-102 was shown to improve sleep quality in patients, while some subjects experienced a 30 percent reduction in pain, the company added.
<span id="midArticle_4"/>The trial was evaluating the effectiveness and safety of the drug against a placebo in 205 patients.
<span id="midArticle_5"/>Tonix said it plans to discuss the trial results and the design for a late-stage trial with the U.S. Food and Drug Administration.
<span id="midArticle_6"/>The company said that despite failing the main goal of the study, data on TNX-102 would support late-stage clinical trials.
<span id="midArticle_7"/>Fibromyalgia is said to be associated with an imbalance of certain chemicals in the brain.
<span id="midArticle_8"/>According to the National Fibromyalgia Association, 3-6 percent of the world's population suffers from fibromyalgia syndrome.
<span id="midArticle_9"/>Tonix shares were trading down about 50 percent $7.00 in premarket trading on the Nasdaq. The stock closed at $13.96 on Friday. (Reporting By Amrutha Penumudi in Bangalore; Editing by Simon Jennings)
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