MedicalResearch.com Interview with: William K. Schmidt, Ph.D. Senior VP Clinical Development Helixmith Co. Ltd.  MedicalResearch.com: What is the background for this study? How common is diabetic peripheral neuropathy and how does it affect patients? Response: According to the Centers for Disease Control and Prevention (CDC), over 34 million people in the United States have diabetes (about 10% of the U.S. population) and about one in four patients do not know that they have it (https://www.cdc.gov/chronicdisease/resources/publications/factsheets/diabetes-prediabetes.htm).  Diabetes can cause significant damage to nerves in the feet, hands, eyes, and other parts of the body. Diabetic peripheral neuropathy (DPN) is the most common form of nerve damage worldwide; it affects approximately half of the patients with diabetes (Iqbal et al., 2018).  In many individuals, severe burning, tingling, “pins and needles,” or cramping pain can occur simultaneously in both feet without external evidence of foot damage. Despite the pain, symptoms may be accompanied by numbness or loss of sensation in the feet. This is called painful diabetic peripheral neuropathy (painful DPN or P-DPN) and may affect up to one-third of the general diabetic population (Yoo et al., 2013). P-DPN may cause increased anxiety and depression, sleep impairment, and difficulties with walking.  Up to one-third of P-DPN patients may require the use of a cane, walker, or even a wheelchair due to extreme foot pain.  Once P-DPN occurs, it may result in a lifetime of pain and disability. FDA-approved daily oral medications often used to treat P-DPN include Neurontin (gabapentin), Lyrica (pregabalin), Cymbalta (duloxetine), and Nucynta ER (tapentadol).  While these “neuropathic pain” medications may dull the pain for some subjects, they produce significant side effects that may be troubling for many patients. Indeed, many patients stop using these pain killers due to lack of effectiveness at doses that they can tolerate (van Nooten et al., 2017) There is also a topical 8% capsaicin patch, but again with limited efficacy. It is well known that the most severely affected patients may require opioid analgesics to control P-DPN (Pesa et al., 2013). None of the currently used medications have disease-modifying effects. However, our new injectable medication is now in advanced clinical development that has the potential disease-modifying effects lasting months after each treatment, with limited or no side effects for most patients aside from brief injection site discomfort. (more…)