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Tonix Pharmaceuticals Completes Pre-IND Meeting With FDA On TNX-201 For Episodic Tension-Type Headache: Clinical Development To Begin In 4Q 2014

NEW YORK, March 3, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a development stage specialty pharmaceutical company, today announced that it recently held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of TNX-201 (single isomer isometheptene, or IMH) for the relief of episodic tension-type headache (ETTH). ETTH is the medically-recognized term for tension headache, a common problem affecting approximately 20% of the global adult population.

"Following this informative meeting with the FDA, we can confirm the initial IND for TNX-201 will not require any additional nonclinical data to support a first-in-man study. This enables us to enter the clinic promptly with minimum risk, which is consistent with our platform of repurposing, reformulating, or rediscovering high impact prescription medications for unmet or under-served needs and particularly for pain syndromes. We are on track to evaluate TNX-201 in a clinical pharmacology study in the fourth quarter of 2014," said Seth Lederman, M.D., president and CEO of Tonix.

"Selecting a single isomer of IMH for development can potentially reduce the toxicity associated with the racemic mixture based on our pharmacology data, which is consistent with the FDA Stereoisomeric Drugs Development Policy. Although the development of TNX-201 will be based on the available information on racemic IMH, the New Drug Application (NDA) approval will conform with the current 505(b)(1) NDA requirement." noted Dr. Lederman.

TNX-201 has the potential to become the first new prescription drug for tension headache in more than 20 years. Currently, the only FDA-approved prescription medications for tension headache contain butalbital. Prescription products containing barbiturates can be habit forming and are associated with the development of Medication Overuse Headache, a chronic syndrome that is difficult to treat. "TNX-201, if approved, will provide people who suffer from tension headaches a treatment alternative to barbiturate drugs, as well as to over-the-counter medicines containing acetaminophen and caffeine," said Dr. Lederman.

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