Use of Medical Food Theramine® Found to be Safer and Less Costly Than NSAIDs for Pain Treatment in Elderly Patients

Pharmacoeconomic Analysis Examines the Additional Cost to Prevent
Gastrointestinal Side Effects and Complications

Theramine® Lowered C-reactive protein (CRP) in Clinical Trial

Los Angeles, October 23, 2012 – Medical food Theramine® should be the preferred treatment for pain when compared to NSAIDs (non-steroidal anti-inflammatory drugs) in elderly patients 65 years and older, according to a pharmacoeconomic analysis conducted by Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM) published in the May issue of the Journal of Pharmacy Research.

The scientific economic paper, “Theramine (A Medical Food) Versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients: A Pharmacoeconomic Analysis,” examines the additional cost burden of the strategies to prevent gastrointestinal side effects and complications. A PDF of the full pharmacoeconomic analysis can be viewed by visiting http://bit.ly/TheramineVsNSAIDs.

“Non-steroidal anti-inflammatory drugs are the leading cause of drug induced morbidity and mortality in the United States,” said David S. Silver, M.D., corresponding author of the pharmacoeconomic analysis, and executive VP of medical and scientific affairs at Targeted Medical Pharma, Inc., which develops and distributes prescription medical foods to physicians, pharmacies and skilled nursing facilities. “Gastrointestinal hemorrhage is the most common concern when using NSAIDs, along with hypertension, edema, renal complication and cardiovascular risk, all which occur at higher rates in elderly patients. Patients over the age of 65 with concomitant medications and disease states are the most likely to suffer serious consequence side effects of NSAIDs.”

The analysis found that the actual cost of using Theramine is considerably lower when compared to the total impact of NSAIDs. Excluding the treatment for hepatic, renal and cardiovascular side effects, the annual cost of generic NSAIDs per 100 pain and inflammation patients is $241,500, compared to an annual cost of $211,200 per 100 patients using Theramine.

“Theramine is a prescription only medical food that is used to treat fibromyalgia, acute and chronic neuropathic or inflammatory pain without risk of gastrointestinal or other side effects,” added Dr. Silver. “The higher acquisition costs for Theramine are offset by the reduction in side effects and need for testing and other protective medications in patients over the age of sixty-five taking NSAIDs, making Theramine a preferred choice over non-steroidal anti-inflammatory drugs in elderly patients.”

Methodology

Safety and efficacy data were derived from two large double-blind controlled trials that compared Theramine to low dose naproxen and ibuprofen, as well as other industry published literature. A total of 256 patients across 12 independent sites 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 greater pain relief than either naproxen at 250mg daily or ibuprofen at 400mg daily. The studies also revealed that Theramine, when administered as a standalone medication and in combination with an NSAID, lowered a statistically significant amount of CRP (C-reactive protein), while an increased CRP level was seen in the naproxen and ibuprofen groups. No side effects from Theramine were reported in the trials and observational reporting after 38,000,000 doses of Theramine showed no gastrointestinal bleeds.

Risk data and rates of gastrointestinal bleeding, morbidity and mortality data were derived from the Medicare database and peer reviewed literature. Medication acquisition costs were determined based on listed average wholesale pricing (AWP). Procedural and hospitalization rates were obtained from the Medicare fee schedule. A cost per life saved analysis was not performed since there is no incremental overall cost increase to the use of Theramine.

Full citation:

“Theramine (A Medical Food) Versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients: A Pharmacoeconomic Analysis.” David S. Silver, M.D.; Elizabeth H. Charuvastra, RN; Lawrence May, M.D.; Stephanie L. Pavlik, CRA; William E. Shell, M.D. Journal of Pharmacy Research (Volume 5, Issue 5); Published online: May 2012.

About Targeted Medical Pharma, Inc.

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 be administered under the ongoing supervision of a physician.

About Targeted Medical Pharma’s Medical Foods

Targeted Medical Pharma, Inc. is a specialty pharmaceutical company that develops and sells 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 foods, as well as 48 convenience packed 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.

Click here to download press release.

Clinical Trials Show Theramine® is Effective at Reducing Inflammation Associated with Chronic Back Pain

Los Angeles, October 18, 2012 – 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.

Full citation:

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.

To be added to Targeted Medical Pharma’s email list please visit: http://www.tmedpharma.com/ir-request-information

 

Targeted Medical Pharma Commences Public Trading of Its Securities

Shares Begin Trading Over-the-Counter Under Symbol “TRGM”

Los Angeles, October, 12, 2012 – Targeted Medical Pharma, Inc., a specialty pharmaceutical company that develops and distributes prescription medical foods to physicians, pharmacies and skilled nursing facilities, today announced that effective today, its common shares will be trading over-the-counter under the symbol “TRGM” on OTC Market Group’s OTCQB market and the Over-the-Counter Bulletin Board (OTCBB). The company’s publicly traded status follows FINRA’s approval of its 15c2-11 filing.

“We are very excited to begin the next phase of the evolution of our company,” said William Shell, M.D., chief executive officer of Targeted Medical Pharma. “With medical foods gaining wider acceptance among physicians and patients, we believe the company is positioned to enjoy further growth, as we increase marketing efforts for our nine proprietary medical food products and focus on the development of new products that address large patient populations.”

Targeted Medical Pharma, Inc.

Targeted Medical Pharma, Inc., is a specialty pharmaceutical company that develops and sells 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 foods, as well as 48 convenience packed kits, which pair a medical food and branded or generic pharmaceutical. These prescription medications 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.

Click here to download press release.

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