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 Therapeutics and 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.
Twitter: @tmedpharma
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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.
Copyright Business Wire 2014