Los Angeles, CA (PRWEB) April 30, 2009
New hope for hundreds of thousands of people suffering from chronic sciatica was revealed this week in a Phase II randomized, double-blind, placebo-controlled trial. Researchers from the Walter Reed Army Medical Center reported(1) that localized (epidural) administration of etanercept, a unique therapeutic that neutralizes TNF (tumor necrosis factor), holds promise as a treatment for sciatica. Epidural etanercept for sciatica was invented by a California physician, Edward Tobinick MD(2). Sciatica, nerve root pain radiating down the leg, is most often associated with a herniated disc in the lower back. Basic science research has suggested that excess TNF, a molecule which amplifies the inflammatory response, is centrally involved in sciatica and other forms of disc-related and neuropathic pain.
The Walter Reed study, published in the May 2009 issue of the journal Anesthesiology(1), provides the first randomized, double-blind, placebo-controlled data supporting the novel concept that etanercept could be used locally for a neurology indication. This concept was pioneered and patented not by the drug's manufacturer, but rather by Dr. Tobinick at the Institute for Neurological Research in Los Angeles. For the past ten years he has been, and is currently, using locally administered etanercept for treatment of patients with intractable sciatica, back and neck pain(3,4,5,6). This type of off-label use is an example of a repositioned use of an existing therapeutic, a topic of increasing interest to the pharmaceutical industry(7).
Also this week, in the May 5, 2009 issue of the journal Neuroscience, Kato and colleagues from the University of California, San Diego(8) reported that locally administered etanercept reaches the inside of injured nerves and reduces pain-related behavior in animals. The Neuroscience study cites three of the previous scientific publications of Dr. Tobinick(3,5,6). These new studies therefore provide further scientific support for the concept of local therapeutic administration of etanercept for disc-related pain.
These publications provide substantial new scientific data. However, FDA-approval is a long and difficult process, and prior to approval drug manufacturers are prohibited by the FDA from promoting any off-label use of any of their medications to the public. Nevertheless, the prospect of a new, non-surgical approach for chronic sciatica is exciting, and further investigation is already underway.
1. Cohen, S.P., N. Bogduk, A. Dragovich, C.C. Buckenmaier, 3rd, S. Griffith, C. Kurihara, J. Raymond, P.J. Richter, N. Williams, and T.L. Yaksh, Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology, 2009. 110(5): p. 1116-26.
2. U.S. patent 6,419,944, filed April 5, 2001; also 6,537,549; and 6,982,089, issued to Edward Tobinick MD and assigned to TACT IP, LLC, and additional patents and related applications, assigned to TACT IP, LLC.
3. Tobinick, E.L. and S. Britschgi-Davoodifar, Perispinal TNF-alpha inhibition for discogenic pain. Swiss Med Wkly, 2003. 133(11-12): p. 170-7.
4. Tobinick, E.L., Targeted etanercept for discogenic neck pain: uncontrolled, open-label results in two adults. Clin Ther, 2003. 25(4): p. 1211-8.
5. Tobinick, E. and S. Davoodifar, Efficacy of etanercept delivered by perispinal administration for chronic back and/or neck disc-related pain: a study of clinical observations in 143 patients. Curr Med Res Opin, 2004. 20(7): p. 1075-85.
6. Tobinick, E., Perispinal etanercept for neuroinflammatory disorders. Drug Discov Today, 2009. 14(3-4): p. 168-77.
7. Tobinick, E., The value of drug repositioning in the current pharmaceutical market. Drug News and Perspectives 2009 Mar-Apr 22(2).
8. Kato, K., S. Kikuchi, V.I. Shubayev, and R.R. Myers, Distribution and tumor necrosis factor-alpha isoform binding specificity of locally administered etanercept into injured and uninjured rat sciatic nerve. Neuroscience, 2009. 160(2): p. 492-500.
Institute for Neurological Research®, a private medical group, inc.
Los Angeles, California 90095
Telephone: (310) 824-6199
Perispinal and epidural administration of etanercept for sciatica are off-label and are patented inventions (see reference 2 above) of Edward Tobinick, MD.