Research & Development
According to the latest International Diabetes Federation (IDF) Diabetes Atlas sixth edition, 382 million individuals suffer from some form of diabetes worldwide 1. Moreover, the number of individuals suffering from diabetes across the globe is expected to increase by 55% in 2035 to 592 million people. Associated worldwide diabetes health care expenditures are estimated to currently be 548 billion USD and forecasted to increase to 627 billion USD by 2035; with low to middle income countries disproportionately burdened by the disease.
According to the American Diabetes Association, there are approximately 25.8 million persons in the U.S. with some form of diabetes (ADA website) and conservative projections estimate that >40 million Americans will have some form of diabetes by 2035 2. The current health care cost of diabetes and its complications in the U.S. is approximately 150 billion USD and is projected to double by 2035 to >300 billion USD 2. Suffice it to say that the current epidemic of diabetes and its complications shows no signs of slowing and will continue to be a significant personal and financial burden on humanity across the globe.
Diabetes is primarily an endocrine disorder involving dysfunctional metabolic regulation of pancreatic, liver, adipose and muscle tissues. Several major complications arise due to metabolic dysfunction including cardiovascular disease, neuropathy, nephropathy, retinopathy and others 3. Of these complications, hyperglycemia mediated dysfunction of the microvasculature along neurological injury contribute to the development of peripheral diabetic neuropathy (PDN) 3, 4. Importantly, PDN affects patients with both Type 1 and Type 2 diabetes with an incidence of approximately 60% (ADA website) costing an estimated $10.9 billion USD for the management of PDN in 2004 alone 5. Current clinical management of PDN is limited in its scope and effectiveness 6. Various therapies include: 1) tight glycemic control, 2) antidepressants, 3) anticonvulsants, 3) opioid analgesics, 4) antiarrythmics, 5) NMDA receptor antagonists, 4) capsaicin and 5) acupuncture 7. However, studies have reported that topical organic nitrate sprays (nitroglycerin & glycerol trinitrate) could provide reduction in pain 8-11. Taken together, it is clear that more effective therapeutic modalities are needed for patients suffering from peripheral diabetic neuropathy.
TV1001SR is a twice-daily orally-dosed slow-release formulation of the FDA-approved therapeutic sodium nitrite. Results from Phase IIa clinical trials support the use of sodium nitrite for the treatment and prevention of peripheral artery disease, and as a non-addictive and cost-effective treatment for diabetic neuropathy.
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