On April 15th, Dong-A ST announced that it successfully completed phase Ⅱ clinical test of 'DA-9801,’ self-developed natural product drug for diabetic neuropathy in the U.S.
The phase Ⅱ clinical test of 'DA-9801’ was conducted on 128 patients in fourteen clinical trial institutions including Johns Hopkins Hospital in the U.S., and it verified that the drug was proven safe and efficient in the comparison of control group on pain intensity after twelve-week-long injection of 'DA-9801.’
“It is hard to find a drug which can relieve the pain of diabetic neuropathy by half,” said Dr. Argoff at Albany University participating in the clinical trial, ”However, The test showed that more than 50 percent of the patients who took 'DA-9801' for twelve weeks experienced the decrease in the pain by half. It is actually an astonishing result.”
'DA-9801' is the natural product drug containing powdered medicine and nipponnica with the effects of pain-killing and neuranagenesis. The phase Ⅱ clinical test of 'DA-9801,’ natural product drug was conducted for the first time as a Korean company after U.S. Food and Drug Administration (FDA) approved the clinical test.
When it comes to clinical tests, skipping phase Ⅰ to phase Ⅱ clinical test is possible not only in the U.S. and Europe but also in the rest of the world in case that the certain natural product drug is proved enough to be used as raw material with safety. Diabetic neuropathy is the disease where hyperglycemia turns metabolism materials into poison and kills or transforms nerve cells especially in fingertips and tiptoes with long nerves in them.
Feeling like having pins and needles and sensory paralysis are those major symptoms of diabetic neuropathy. The exact pathogenesis of diabetic neuropathy is unknown, and its treatment is focused on medicine treatment on the central nervous system to relieve the pain.
“Dong-A ST succeeded in completing the phase Ⅱ clinical test of 'DA-9801' for the first time as a Korean pharmaceutical company,” said Park Chan-il, CEO of Dong-A ST, “With this momentum, I will try to advance our launch of Korean natural product drugs into the global market.”
By Lee Kyung-ho