Los Angeles, CA, September 23, 2014 — Targeted Medical Pharma, Inc. (OTCQB: TRGM) a drug discovery and development company, announced the results of a second, double-blind clinical trial which confirmed that Theramine was shown not only to be more effective than ibuprofen in reducing low back pain, but also demonstrated a significant reduction in measures of inflammation.
In this 28 day, multi-center trial, subjects taking Theramine as either a standalone medication or in conjunction with a low dose ibuprofen, demonstrated a significant reduction in both low back pain and inflammation when compared to baseline and ibuprofen. Ibuprofen alone did not impact back pain and showed increased inflammation when compared to baseline. The results of this study have been published online in the American Journal of Therapeuticsand can be viewed by visiting http://bit.ly/theraminehelpsbackpain.
“The overuse of NSAIDs is a growing concern among physicians and patients due to the potential stomach bleeding, heart attacks and strokes that are outlined on the black box warning associated with every NSAID product,” said William Shell M.D., cardiologist, CEO, and CSO at Targeted Medical Pharma. “The current recommendation of the American Geriatric Society is to restrict or eliminate the use of NSAIDs in patients 65 years of age and older due to their potential risks. The results of this and previous studies confirm that Theramine can be used as a safe and effective alternative to NSAIDs and potentially other dangerous pain medications for patients suffering from chronic pain.”
This trial examined the unique nutritional needs of patients with chronic back pain who at baseline showed reduced concentrations of the specific amino acids involved in reducing pain and inflammation. Subjects taking Theramine as a standalone medication showed significant improvements in plasma concentrations of these amino acids compared to baseline in addition to a reduction in pain and inflammation as measured by the Roland-Morris Pain Scale, Oswestry Disability Index, C-reactive protein (CRP) and Interleukin-6 (IL-6). Subjects taking ibuprofen alone showed no significant changes in these parameters. The results of this trial suggest that addressing the unique amino acid deficiencies associated with chronic pain using an amino acid based medical food can be significantly more effective at reducing pain and inflammation than NSAID therapies.
About Targeted Medical Pharma, Inc.
Targeted Medical Pharma, Inc. is a publicly traded, Los Angeles-based biotechnology company that is committed to drug discovery and development. The company currently develops and distributes amino acid based medical foods, a rapidly growing sector of medication technology, for the treatment of chronic disease, including pain syndromes, peripheral neuropathy, hypertension, obesity, sleep and cognitive disorders using the patented system of Targeted Cellular Technology.
The company also develops a line of dietary supplements designed to support health and wellness. TMP currently manufactures 10 proprietary amino acid based medical foods, and recently launched its first dietary supplement, Clearwayz™. The products are sold directly to physicians and pharmacies in the U.S. The Company is also developing nutrient-based systems for oral stimulation of progenitor stem cells that differentiate into neurons, red blood cells, pituitary hormones including IGF-I.
Forward Looking Statement
This press release may contain forward-looking statements related to Targeted Medical Pharma’s business strategy, outlook, objectives, plans, intentions or goals. The words “may,” “will,” “should,” “plans,” “explores,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” and similar expressions, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Actual results could differ materially. Targeted Medical Pharma expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based.
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