Prescription-Only Medical Foods Found Beneficial in Clinical Practice

Expert Panel of Doctors Review Clinical Data on Safety and Efficacy of Medical Foods in Pain Management and Sleep Disorders

Free Replay of Webcast Available for Download

LOS ANGELES--()--According to an expert panel assembled by Physician Therapeutics, the use of prescription-only medical foods, which require the ongoing supervision of a physician, may be particularly useful in the nutritional management of pain, obesity, sleep disorders associated with depression and anxiety, as well as cognitive disorders.

In a webcast discussion held on June 29, 2012 entitled, “Use of Medical Foods in Clinical Practice,” panelists reviewed clinical data from two double-blind clinical trials of Theramine®, an Rx medical food for pain disorders, and one double blind clinical trial of Sentra PM®, an Rx medical food for sleep disorders associated with depression. Following the data presented, each panelist discussed their professional experience using medical foods in their respective clinical practices. A replay of the 60-minute webcast may be found online at http://bit.ly/MedicalFoodsinClinicalPracticeRebroadcast.

David S. Silver, M.D., board certified rheumatologist, executive VP of medical and scientific affairs at Targeted Medical Pharma, and co-author of a recently published study of Theramine in the March issue of the American Journal of Therapeutics, reviewed the clinical data that demonstrated Theramine to be a safe and effective treatment for pain and inflammation associated with chronic back pain.

“In two large double-blind controlled trials, which included almost 250 patients, we found a statistical improvement in the groups taking Theramine, using a measure of pain and functional movement,” said Dr. Silver. “Maybe the most interesting part of the study is looking at the CRP data, where patients taking naproxen alone actually showed an increase in CRP, and patients on Theramine had a greater than 60 percent reduction in this inflammatory marker.”

CRP is the inflammatory marker C-reactive protein and naproxen is a commonly used nonsteroidal anti-inflammatory drug (NSAID).

Commenting on the trial comparing Theramine with ibuprofen, Dr. Silver said, “Patients with chronic back pain have significantly reduced levels of several of the amino acids that are involved in pain transmission, neurotransmission, as well as inflammation. What is most interesting is that the patients taking Theramine showed a substantial improvement in the levels of these semi-essential amino acids. More importantly, the improvement in amino acids directly correlates with clinical benefit.”

In the Sentra PM trial for the management of sleep disorders Dr. Silver said, “What we see when we treat patients with Sentra PM is improved time to fall asleep, and improved restorative sleep, which is something that may be the most important. One of the big complaints we hear about traditional sleep aids is that they might improve quantity of sleep, but they do not improve sleep quality. So patients might sleep, but not necessarily feel rested.”

Panelist Jodi L. Berg, ND, a leading naturopathic doctor in Washington State, commented that multiple studies have shown that inflammation is the root cause of most disease. “With this technology, we are able to get, on a cellular level, the body back to homeostasis,” said Dr. Berg. “It’s just the beginning of a change in medicine where the body has the vitality to heal, and with medical food technology, we are now able to stop inflammation and help bring patients back to optimal health.”

Gabriel J. Halperin, DPM, a highly respected podiatrist in Los Angeles, who specializes in treating diabetic neuropathy and the third panelist in the session, refined his description of medical foods as amino acid targeted therapy. He added, “Since we started using amino acid targeted therapies, we have been able to cut out the need for many narcotics in pain therapy. But if they are needed, adding Theramine enables us to use very low doses of neuropathy medications – much lower doses than are typically prescribed.” Dr. Halperin noted that medical foods also fit into pain treatment regimens for the elderly where the usual pharmaceuticals may not be well tolerated.

In concluding, moderator William Shell, M.D., inventor of Targeted Cellular Technology™, CEO of Targeted Medical Pharma, and board certified cardiologist, addressed the unique scientific principles underlying the company’s prescription medical foods: “Clinical data show that medical foods improve the metabolic efficiency of neurotransmitter synthesis, which is a precursor to restoring cellular signaling. As such, all of our products are amino acids designed to actively stimulate the production of neurotransmitters, and the manner in which we manufacture our products makes them qualitatively different because their uptake is enhanced and more effective.”

About Physician Therapeutics’ Medical Foods

Physician Therapeutics’ 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 Physician Therapeutics and Targeted Medical Pharma, Inc.

Physician Therapeutics is a division of Targeted Medical Pharma, Inc., 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 food products, 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.

Contacts

PondelWilkinson
George Medici | Gmedici@pondel.com
Ron Neal | Rneal@pondel.com
310-279-5980
or
Physician Therapeutics
Marcus Charuvastra | marcusch@ptlcentral.com
310-474-9809

Release Summary

Physician Therapeutics held a webcast discussion on June 29, 2012 entitled, “Use of Medical Foods in Clinical Practice."

Contacts

PondelWilkinson
George Medici | Gmedici@pondel.com
Ron Neal | Rneal@pondel.com
310-279-5980
or
Physician Therapeutics
Marcus Charuvastra | marcusch@ptlcentral.com
310-474-9809