Positive results have been reported from a phase 2 study of TV1001sr (TheraVasc, Inc.), an investigational sustained-release, nonaddictive, nonsedating pain medication, for the treatment of patients with pain associated with diabetic neuropathy. The treatment improved pain scores and the neuropathic pain symptom inventory.
In a previous phase 2 study, the immediate-release version of the medication, known as TV1001, improved vascular health while significantly reducing pain in diabetic patients with peripheral arterial disease (PAD). TV1001 was also shown to be safe, although some subjects developed headaches. The sustained-release version has received no such complaints.
“We noticed statistically significant improvements in the neuropathic pain symptom inventory, which is a standard screening tool for the severity of diabetic neuropathy pain,” said investigator Dr. Amol Soin. “Patients also noted a decrease in overall and continuous pain scores by as much as 50%. Pain reduction of this magnitude in patients with diabetic neuropathy is quite significant and better than a lot of current treatments.”
TV1001sr is a non-narcotic repurposed drug that has been shown to stimulate angiogenesis and to inhibit inflammation in animal models of ischemia.
In two independent clinical trials, patients with chronic pain due to either PAD or diabetic neuropathy reported significantly less pain—at 10 weeks and 13 weeks—after being treated with TV1001 or TV1001sr.
Because of its mechanism of action, TheraVasc believes that TV1001sr will ultimately provide benefit to patients with chronic pain resulting from a number of conditions associated with microvascular disease. The company plans to conduct phase 3 studies in patients with systemic sclerosis, an autoimmune disease associated with microvascular damage in the hands, leading to severe pain and ulcers.
More than 300 million people worldwide have diabetes—a number that is expected to increase by more than 50% by 2035. TV1001sr uses sodium nitrite to treat diabetic pain by stimulating blood vessels. The medication is also nonaddictive and nonsedating. The latter features are important because prescription drug abuse/overdose is one of the leading causes of preventable death in the United States.
Source: PR Newswire; August 2, 2016.