Tonix Pharma's Pain Drug Fails Mid-Stage Study

By Reuters Staff

September 30, 2014

(Reuters) - Tonix Pharmaceuticals Holding Corp said its lead pain drug failed the main goal of a mid-stage study.

The drug, TNX-102, is being tested to treat fibromyalgia, a chronic syndrome characterized by widespread pain and lack of sleep.

The treatment failed the main goal of reducing pain experienced by patients by the 12th week of the trial, Tonix said.

However, TNX-102 was shown to improve sleep quality in patients, while some subjects experienced a 30% reduction in pain, the company added.

The trial was evaluating the effectiveness and safety of the drug against a placebo in 205 patients.

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.

The company said that despite failing the main goal of the study, data on TNX-102 would support late-stage clinical trials.

Fibromyalgia is thought to be associated with an imbalance of certain chemicals in the brain.

According to the National Fibromyalgia Association, 3% to 6% of the world's population suffers from fibromyalgia syndrome.

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