Clinical Trial Shows Theramine® is Safe and Effective for Chronic Back Pain

Los Angeles, June 11, 2012 – Physician Therapeutics, Inc., a division of Targeted Medical Pharma, Inc., a  specialty pharmaceutical company that  develops and distributes specialty pharmaceuticals to physicians, pharmacies and skilled nursing facilities, published results from a clinical trial of the company’s proprietary medical food Theramine®. The trial demonstrated improvement in chronic low back pain in 129 subjects when administered as a standalone therapy or in conjunction with low dose naproxen for 28 days.  The results of this study have been published in the March issue of the American Journal of Therapeutics and can be viewed by visiting http://bit.ly/Theramine-Clinical-Trial.

“This study indicates that Theramine is a safe and effective treatment for pain and inflammation 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.   

The double-blind, three-arm, study included 129 patients across 12 independent sites that were randomized for treatment with Theramine alone, Theramine with naproxen 250mg and  naproxen 250mg alone.  Results showed that both the Theramine group and combined therapy group (Theramine with naproxen)  showed statistically significant improvement compared with the naproxen group (p<0.05). The Theramine and naproxen groups showed functional improvement when compared to the naproxen-only group as assessed by the Roland-Morris Disability Questionnaire Pain Scale and Oswestry Disability Index. Theramine showed a statistically significant reduction in the inflammatory marker C-reactive protein when compared to baseline and naproxen.

In the study, which was completed in 2009, subjects underwent baseline screening, informed consent and an initial screening questionnaire.  Each week, subjects would repeat completion of the endpoint measurements.  At baseline and day 28, blood samples were collected from each subject.  The primary endpoint was reduction in the subject’s perception of their chronic low back pain.  Secondary endpoints were measured by comparing the subject’s baseline and day 28 blood samples, as well as reports of rescue medication utilized and additional functionality scales.

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.

 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 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.