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TONIX Pharmaceuticals Holding Corp. |
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509 Madison Ave. Suite 306
New York, NY 10022 USA
phone:212 980-9155
fax:212 923-5700
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| Symbol |
TNXP |
| Exchange |
OTC BB |
| Founded |
2007 |
| Employees |
3 |
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| www.tonixpharma.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| TONIX Pharmaceuticals is developing new therapies for challenging disorders of the central nervous system. The Company targets conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among both patients and physicians. Its most advanced product candidates are TNX-102, for fibromyalgia, and TNX-105 for PTSD. |
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| Management |
| Seth Lederman, MD, Chief Executive Officer & Chairman
Benjamin A. Selzer, Chief Operating Officer
Rhonda B. Rosen, Chief Financial Officer |
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| Keywords |
| Fibromyalgia, Post-traumatic stress disorder, reformulation |
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| Description |
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TONIX Pharmaceuticals develops high-value prescription therapeutics for chronic Central Nervous System (CNS) conditions. The Company’s lead programs are potential new treatments for fibromyalgia (FM) and post-traumatic stress disorder (PTSD). In each of these new treatment regimens, TONIX seeks to use new doses and formulations of the “classic” ingredient cyclobenzaprine (CBP). CBP is the active ingredient in two FDA-approved prescription muscle relaxants currently on the market, but despite widespread use, CBP’s biological mechanism of action has not yet been fully characterized. TONIX’s new formulations of CBP are optimized for bedtime use, as a recent Phase IIa study published in the Journal of Rheumatology November 2011 issue demonstrates. This earlier-stage biotechnology company believes that a number of other “classic” ingredients also offer significant opportunities; in order to maximize corporate potential, TONIX Pharmaceuticals has established parallel businesses to efficiently develop and distribute its products. |
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| Products / Services |
TNX-102 and TNX-103 are pills containing cyclobenzaprine that are designed for bedtime management of Fibromyalgia Syndrome (FMS) and Post-Traumatic Stress Disorder (PTSD), respectively. Based on our formulation technology, we believe these products will provide more predictable effects and less next-day drowsiness than commercially available immediate-release cyclobenzaprine tablets.
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| Technology / Differentiation |
| TONIX Pharmaceuticals is developing TNX-102 as a treatment for fibromyalgia syndrome (FMS). TNX-102 is a novel formulation of cyclobenzaprine, a widely prescribed muscle relaxant with an established safety profile. Several large clinical studies have confirmed cyclobenzaprine's safety and tolerability. |
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| Market / Customers |
We believe certain of our drug development candidates, including TNX-102 and TNX-105, can be marketed more effectively by companies that already have significant drug development and marketing capabilities. We would seek to enter into collaborations with pharmaceutical or biotechnology companies for the commercialization of these product candidates at the times we believe most effective.
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| Competitors / Substitutes / Alternatives |
Until 2007, there were no FDA-approved drugs to treat Fibromyalgia Syndrome (FMS).
In 2007, Lyrica (pregabalin) became the first medicine approved by the FDA for the management of FMS. Lyrica previously had been approved and marketed to treat pain in other conditions. FMS shares a number of symptoms with depression, and a number of FMS patients are believed to experience depression as a co-existing condition. In 2008, Cymbalta (duloxetine) became the second medicine approved by the FDA for the management of FMS. Cymbalta previously had been approved and marketed to treat depression. Savella (milnacipran) was the third medicine approved by the FDA for the management of FMS. Savella's active ingredient, milnacipran, is approved in Europe to treat depression.
A potential competitor for treating FMS symptoms at bedtime is Rekinla which is being developed by Jazz Pharmaceuticals, or Jazz. The active ingredient in Rekinla is sodium oxybate, which is the active ingredient in XYREM, approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy, the sudden loss of muscle tone, in adult patients with narcolepsy.
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| Strategy |
We believe our lead product candidates may be approvable under pathways that are potentially shorter than those typically available for novel pharmaceutical compounds. By focusing on developing new formulations of approved drugs for new uses, we believe that we will be able to use the Section 505(b)(2) pathway for FDA approval. This pathway can reduce the time and expense required for our development programs by allowing our use of previously-generated safety and efficacy information regarding the active pharmaceutical ingredients in our lead product candidates to support the filing and approval of our NDA application. Doing so may help limit the size and scope of our preclinical and clinical trials.
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| Funding |
| TONIX is a public company. |
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| Status |
| A double blind, randomized trial (Phase 2a) in 36 subjects with Fibromyalgia Syndrome (FMS) showed the bedtime cyclobenzaprine improved musculoskeletal pain, tenderness and depressed mood. After a pharmacokinetic study on our commercial formulation, we plan a Phase 2b study. |
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