November 2nd, 2010
Grants Cover Theramine®, Sentra PM®, Sentra AM® and GABAdone®
Los Angeles, CA, Nov. 1, 2010 /Targeted Medical Pharma Inc. a Specialty Pharma company developing proprietary medical food products distributed through subsidiary Physician Therapeutics announced it has been awarded $733,429.00 in government grants. Under the recently enacted Patient Protection and Affordable Care Act, cash grants were awarded to Qualifying Therapeutic Discovery Projects that showed significant potential in producing new and cost-saving therapies, support job growth and increase U.S. competitiveness. Grants were awarded through a competitive application process supervised by the National Institutes of Health. All three of the Company’s applications were awarded. The first involved the reduction of gastrointestinal hemorrhage by Theramine associated with treatment of back pain syndromes. The second involves reduction of the side effects associated with sleep disorders in the elderly with Sentra PM and GABAdone ,and the third addresses a safe and effective treatment for symptoms of Gulf War Illness with Sentra PM and Sentra AM. The Company will be able to expand the growth of these and other innovative products with these funds.
About Targeted Medical Pharma Inc.
Targeted Medical Pharma Inc. is a leader in the development of therapeutic systems for the nutritional management of chronic diseases. The Company strives to optimize patient care with safe and clinically effective prescription Medical Food products, such as Theramine®, GABAdone®, Sentra AM®, Sentra PM®, Trepadone®, and Hypertensa®, as well as distributing generic and branded drugs through subsidiary company, Physician Therapeutics.
Source: Targeted Medical Pharma Inc.
Tags: Funds, Grants, Targeted Medical Pharma
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September 29th, 2010
A Double-Blind Controlled Trial of a Single Dose naproxen and an Amino Acid Medical Food Theramine for the treatment of Low Back Pain
To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was present for at least 6 weeks and was not mild. Patients were randomly assigned to receive medical food alone (n = 43), naproxen alone (250 mg/d, n = 42), or both medical food and naproxen (n = 44). All patients were assessed by using Roland-Morris Disability Questionnaire, Oswestry Low Back Pain Scale, Visual Analog Scale Evaluation and laboratory analysis performed at baseline and at 28 days for assessing the safety and impact on inflammatory markers, which included complete blood counts, C-Reactive protein (CRP), and liver function (alkaline phosphatase, aspartate transaminase, and alanine transaminase). At baseline, there were no statistically significant differences in low back pain when assessed by Roland-Morris function or Oswestry assessments nor were there differences in the blood indices of inflammation. At day 28, both the medical food group and combined therapy group (medical food with naproxen) were statistically significantly superior to the naproxen-alone group (P , 0.05). The medical food and naproxen group showed functional improvement when compared to the naproxen-alone group. The naproxen-alone group showed significant elevations in CRP, alanine transaminase, and aspartate transaminase when compared with the other groups. Medical food alone or with naproxen showed no significant change in liver function tests or CRP, with medical food potentially mitigating the effects seen with naproxen alone. The medical food (Theramine) appeared to be effective in relieving back pain without causing any significant side effects and may provide a safe alternative to presently available therapies.
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April 20th, 2008
A Randomized Placebo Controlled Trial of an Amino Acid Preparation on Timing and Quality of Sleep
William Shell, MD, Debbie Bullias, B.S, Elizabeth Charuvastra, RN, Larry May, MD and David Silver, MD
Introduction
The management of sleep disorders continues to be a treatment challenge because hypnotic drugs have therapeutic limitations and dose related side effects. Hypnotic drugs may abolish stage IV sleep, reduce REM sleep, contribute to morning grogginess, or induce residual cognitive dysfunction. Tolerance and long-term dependency also occur. Medications such as tricyclic antidepressants and antiepileptics produce less dependency but have other side effects such as dry mouth and dizziness. The inherent difficulties with these drugs are magnified by the large number of people who suffer from sleep disorders. Even a small incidence of side effects is significant when the population at risk is large.
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