Dr. Seth Lederman, physician, scientist and entrepeneur for specialty pharmaceuticals , is on a mission to improve the quality of life of people suffering from chronic pain and other symptoms associated with primary fibromyalgia.
Lederman, co-founder and CEO of TONIX, a specialty pharmaceutical company headquartered in New York City, is working on a drug he says is a “game-changer” for people with fibromyalgia, a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.
Fibromyalgia amplifies painful sensations at 18 tender points by affecting the way your brain processes pain signals.
Five million Americans, 90 percent of them women, currently suffer from fibromyalgia, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health.
However, Dr. Lederman said in an interview, only about 2.7 million cases are diagnosed, meaning millions of others who have the condition might not know it, or they are suffering without a formal diagnosis.
Fibromyalgia symptoms can start as early as adolescence in either sex but tend to occur most often in adult females. Typically, symptoms progress with age, worsening in your 40s and 50s.
About 90 percent of fibromyalgia patients suffer from sleep issues. Specifically, they don’t wake up in the mornings refreshed. Evidence shows when restorative sleep is improved for fibromyalgia suffers, other debilitating symptoms associated with the condition also improve.
The converse is also true, Lederman said. Sleep deprivation worsens ]]>symptoms.]]>
“For me, it was frustrating that the medical community believes fibromyalgia and fibromyalgia drugs are somehow lifestyle drugs. I don’t think of it that way at all,” said Lederman.
“I think they are nearly as important as life-saving drugs because fibromyalgia can take over the life of someone affected by it. Our goal is to give better medicines to these patients; to give them their lives back.”
Fibromyalgia can be difficult to diagnose. Research shows that people with fibromyalgia typically see many doctors before receiving the diagnosis.
One reason for this may be that pain and fatigue, the main symptoms of fibromyalgia, overlap with those of many other conditions. And because there is no generally accepted, objective test for fibromyalgia, some doctors unfortunately may conclude that a patient’s pain is not real, or they may tell the patient there is little they can do, according to NIAMS.
The FDA has approved three drugs for treatment of fibromyalgia, the analgesic pregabalin (Lyrica®), and two antidepressants, duloxetine (Cymbalta®) and milnacipran (Savella®). However, Lederman said that none of these drugs specifically improves the quality of sleep that a fibromyalgia suffer gets.
His approach is different: “Improve sleep quality to alleviate the pain and mood symptoms that affect fibromyalgia patients during the day.”
TONIX recently concluded Phase 2 clinical trials on a drug TNX-102 SL, (cyclobenzaprine), a compound that’s FDA-approved as a muscle relaxant but has off-label use as a slow-acting restorative sleep aid for patients with fibromyalgia.
In the double blind, randomized, placebo-controlled study involving 36 patients, half were given TNX-102 SL, administered as an under-the-tongue bedtime treatment for fibromyalgia. The other half were a control group receiving a placebo. The study results were published in The Journal of Rheumatology.
Patients given the sleep aid, on average, experienced decreased pain and other fibromyalgia symptoms by 26 percent. The control group saw no change.
TONIX is moving forward on its final phase of clinical trials toward gaining FDA approval. The first, a large 12-week study at 12 sites around the country, is expected to start in August 2013. The results of that study are expected at the end of the year.
A second pivotal study will enroll patients in a few years. If all goes as expected, the drug could gain FDA approval for distribution in 2017.
In the meantime, if you suffer from non-restorative sleep, check out these helpful Tips for Good Sleep.
Lynette Summerill is an award-winning writer and Scuba enthusiast who lives in San Diego with her husband and two beach loving dogs. In addition to writing about cancer-related issues for EmpowHER, her work has been seen in publications internationally.
Interview Dr. Seth Lederman, President and CEO, Tonix. May 6, 2013
The Effects of Bedtime Very Low Dose Cyclobenzaprine on symptoms and sleep physiology in patients with fibromyalgia syndrome: a double-blind randomized placebo-controlled study. Moldofsky H, Harris HW, Archambault WT, Kwong T, Lederman S. J Rheumatol. 2011 Dec; 38(12):2653-63. doi: 10.3899/jrheum.110194. Epub 2011 Sep 1.
Abstract at: http://www.ncbi.nlm.nih.gov/pubmed/21885490
Questions and Answers about Fibromyalgia. National Institute of Arthritis and Musculoskeletal and Skin Disease. August 2012.
Fibromyalgia. Mayo Clinic.
Access at: http://www.mayoclinic.com/health/fibromyalgia/DS00079 and http://www.mayoclinic.com/health/medical/IM02372
Reviewed May 7, 2013
by Michele Blacksberg RN
Edited by Jody Smith