Clinical Trials Show Theramine® is Effective at Reducing Inflammation Associated with Chronic Back P
Clinical Trials Show Theramine®is Effective at Reducing Inflammation Associated with Chronic Back Pain
LOS ANGELES--(BUSINESS WIRE)-- Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM) reported today that the prescription only medical food Theramine is an effective medication for reducing inflammation associated with pain syndromes. Theramine has been the subject of two large double-blind, randomized, multi-center trials, which compared Theramine to low dose naproxen and ibuprofen. 256 subjects participated in the two studies across 20 independent sites that were randomized for treatment to receive Theramine alone (two capsules twice daily), NSAID or a combination of both. In both studies, Theramine showed statistically significantly reduction in inflammation as measured by inflammatory markers and improvement in low back pain than either naproxen at 250mg daily or ibuprofen at 400mg daily.
In the first of the two trials, published in the March, 2012 American Journal of Therapeutics, Theramine when administered as a standalone medication lowered CRP (C-reactive protein) 65% and when administered in combination with a 250mg naproxen lowered CRP 33% compared to baseline. In this study, a 68% increase in CRP levels was seen in the naproxen alone group compared to baseline. The full study can be viewed at http://bit.ly/Theramine-Clinical-Trial.
The second of the two double blind trials compared Theramine to ibuprofen for the treatment of low back pain, which was presented in September, 2012 at PainWeek in Las Vegas, Nevada and will be presented at the 118th Annual Meeting of AMSUS in Phoenix, Arizona on November 13, 2012. In this study, Theramine when administered as a standalone medication lowered CRP 47% and IL-6 23% and when administered in combination with a once daily 400mg ibuprofen lowered CRP 36% and IL-6 41% compared to baseline. In this study, a 60% increase in CRP was measured in the ibuprofen alone group compared to baseline. No serious side effects were reported in both trials.
"These studies indicate that Theramine is not only an effective pain medication but also an effective anti-inflammatory agent for pain and associated with chronic back pain without the concern of gastrointestinal bleeding or other serious side effects such as hypertension," said David Silver, M.D., co-author of the study and executive vice president of medical and scientific affairs at Targeted Medical Pharma, Inc.
"A double-blind controlled trial of a single dose naproxen and an amino acid medical food Theramine for the treatment of low back pain." William E. Shell MD, Elizabeth Charuvastra RN, Lawrence May MD, Debora H. Bullias BS CRA, David S. Silver MD. American Journal of Therapeutics (Volume 19); Published online: March 2012.
"Theramine vs. Ibuprofen for the safe and effective management of chronic low back pain and Inflammation" William E. Shell MD, David S. Silver MD, Fred McCall-Perez PhD, Stephanie Pavlik CRA. The Karen Rieder Federal Nursing Poster Session in conjunction with the 118th Annual Meeting of AMSUS in Phoenix, Arizona.
About Targeted Medical Pharma's Medical Foods
Targeted Medical Pharma's medical foods are amino acid based, FDA-regulated medications specially formulated to meet the body's increased nutritional requirements of disease. They are a safe and effective option for treating pain syndromes, sleep disorders and obesity without harmful side effects. Physician Therapeutics' medical food products are available by prescription only and must administered under the ongoing supervision of a physician.
About Targeted Medical Pharma, Inc.
Physician Therapeutics is a division of Targeted Medical Pharma, Inc., a specialty pharmaceutical company that develops and distributes prescription medical foods to physicians, pharmacies and skilled nursing facilities for the treatment of chronic disease including pain syndromes, obesity, and sleep and cognitive disorders. Based in Los Angeles, the company's proprietary pharmaceutical therapeutic systems are sold in the United States and Japan. The company manufactures nine proprietary medical food products, as well as 49 convenience pack kits, which pair a medical food and branded or generic pharmaceutical. These prescription medical food products and therapeutic systems represent a novel approach to the management of certain disease states, focusing on safety and efficacy without the deleterious side effects of traditional, high dose prescription drugs.
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