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Tonix: a small biotech company with the potentially huge key to the Fibromyalgia puzzle

Sunday 28 October 2012


An article promoting US biotech company Tonix to potential investors that was published on the business website Seeking Alpha:


MoneyTonix: A Small Biotech With The Potentially Huge Key To The Fibromyalgia Puzzle

By Jason Napodano, CFA
October 25, 2012

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

The purpose of this article is to introduce investors to Tonix Pharmaceuticals (TNXP.OB) and the company's very low dose sublingual formulation of cyclobenzaprine for the treatment of fibromyalgia. We will start off with an introduction to fibromyalgia and existing treatment options, a brief history of cyclobenzaprine and how we believe it could be an effective treatment option for the disease, and then conclude with an overview of Tonix's development plans and clinical data to date.

What is Fibromyalgia?

Fibromyalgia Syndrome ("FM") is a complex medical disorder characterized by widespread musculoskeletal pain, fatigue, lack of sleep, and mood and memory issues. The pain associated with FM is often described as a constant dull ache or burning sensation, typically arising from the muscles along the back, neck and shoulders. FM tender points are identified by applying pressure to specific areas of the body, including the back of the head, between the shoulders, along the neck, the upper chest, the hips, and the knees.

The FM diagnostic criteria, established by the American College of Rheumatology (ACR) in 1990, includes a history of widespread pain in all four quadrants of the body for a minimum duration of three months, and pain in at least 11 of the 18 designated tender points when a specified amount of pressure is applied (Figure 1).

Picture 2

Besides the dull aching pain and fatigue, patients with FM often also experience mood and psychological disorders such as anxiety and depression. Many people who have fibromyalgia also have tension headaches and temporomandibular joint disorders. The symptoms are often worse in cold or damp weather.

People with FM tend to wake up with body aches and stiffness. For some patients, pain improves during the day and gets worse at night. However, fatigue and sleep problems are common in almost all patients. The National Pain Foundation estimates that nearly 90% of all FM patients have sleep problems. Patients with FM often report waking up tired, even after sleeping a long period of time. Others report frequent awakenings due to pain, sleep apnea, and restless leg syndrome in the middle of the night. Almost all FM patients report memory and concentration problems associated with the lack of sleep and distracting pain.

These sleep and concentration problems, referred to as "fibro-fog," severely affect many FM patients to the point where employment is difficult to obtain and/or maintain. Approximately 20% of FM patients file some form of disability claim. Approximately 70% of FM patients report difficulty in conducting normal daily tasks, such as light housework. Chronic fatigue syndrome ("CFS") has similar characteristics to FM, and patients are often diagnosed as having both FM and CFS.


The causes of FM are largely idiopathic, but common comorbid conditions include hypothyroidism, Lyme disease, endometriosis and irritable bowel syndrome. Physical trauma, surgery, infection, and psychological stress may bring about the onset of FM. In fact, stress is thought to play a significant role in the development of FM. There is a high correlation (approximately 42%) between the development of FM and post-traumatic stress disorder (PTSD).

Medical & Psychiatric Comorbidity:(click to enlarge)Picture 1

There is evidence that genetic factors may also play a role in the development of FM. Research has demonstrated that FM is potentially associated with polymorphisms of genes in the serotoninergic, dopaminergic and catecholaminergic systems. Many researchers and physicians believe that dopamine dysfunction is centrally responsible for the symptoms associated with FM. Others believe that decreased serotonin levels are involved in the pathophysiology of FM.

Increasing attention is being devoted to irregularities of the central nervous system as the underlying mechanism of FM. Patients with FM commonly have elevated corticotrophin releasing hormone (CRH) and elevated Substance P in the cerebrospinal fluid, and increased activated mast cells and chemokines (MCP-1 and IL-8) in the blood.


The National Institutes of Health (NIH) estimates that FM affects approximately 5 million adult Americans, or roughly 2% of the general population. The American Fibromyalgia Syndrome Association (AFSA) pegs the prevalence higher, at approximately 3 to 5% of the general population. These statistics are in agreement with the National Fibromyalgia Association (NFA), which estimates approximately 10 million Americans with FM.

Diagnosis is usually made between the ages of 20 to 50 years, but the incidence of FM rises with age. In fact, by age 80, approximately 8% of adults meet the ACR classification of FM. Diagnosis is often done by a rheumatologist (~42% of the time) or general practitioner (~35% of the time).

Women outnumber men diagnosed with FM by 9 to 1. Many female FM patients report flare-ups associated with their menstrual cycle. As noted above, there is a high correlation of FM and endometriosis. FM is often seen in families, among siblings or mothers and their children as well. Risk in developing FM increased by 8.5x if a first-degree family member has been diagnosed with FM.

…Treatment Options…

FM is a relatively new diagnosis. Prior to the 1990s, it was often incorrectly diagnosed as osteoarthritis or chronic fatigue syndrome. In fact, a survey conducted by Russell K. Portenoy, MD, Chairman and Gerald J. Friedman Chair in Pain Medicine and Palliative Care at the Departments of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, NY, in 2007 found that 46% of newly diagnosed FM patients (n=2,596) consulted between 3 and 6 physicians before being finally being diagnosed with FM.

There is no cure for FM. Treatment typically consists of symptom management. Beside cognitive behavioral therapy and physical therapy, data suggests that FM patients are high pharmacological treatment seekers. Over 50% of FM patients visit their treatment physician over five times a year. Nearly three-fourths spend between $100 and $500 per month on OTC medications and nearly two-thirds spend the same amount on prescription medications.

FM is a highly complex disease, with manifestation of pain, mood and psychological disorders, and sleep disturbances. The NFA notes healthcare practitioners should "[e]stablish a multifaceted and individualized approach…" for each specific patient depending on the severity of the symptoms in pain, mood, and sleep. There is no universally accepted standard-of-care. As such, multi-pharmacology is the norm for treating patients with FM.


The full article, with comments, appears here.


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