Clinical stage pharma company NeuroDerm Ltd. says it has started to enrol patients in its long-term safety study (trial 012) of a continuously administered subcutaneous levodopa/carbidopa (LD/CD) formulation.
We’ve followed the story of NeuroDerm for some time now, the “medical device” aspect coming from the way its Pa.rkinsons Disease drug is delivered
The one-year international, open label study will investigate the long-term safety of low and high dose regimens of the drug tagged ND0612. The study is expected to enroll approximately 100 patients, including those who have previously completed the company’s phase 2 and 3 studies as well as new patients. At least 50 patients will be treated with the highest dose regimen. ND0612, continuously administered through a belt pump, is designed to maintain steady LD/CD levels to improve motor fluctuations that cannot be adequately controlled with oral therapy and, in the case of advanced patients, provide an alternative to treatments requiring surgical intervention.
“This trial is intended to produce long-term evidence of the safety profile of ND0612 as a viable new treatment option for patients with Parkinson’s disease, and a non-surgical alternative for advanced patients who suffer motor complications, who can no longer be controlled with current best standard of care oral therapies,” said Sheila Oren, MD, MBA, Vice President of Clinical and Regulatory Affairs of NeuroDerm. “Previous shorter-term studies with ND0612 have shown clinical benefits that were similar to those obtained with invasive surgical procedures while exhibiting a good safety profile, in contrast to the potentially serious and sometimes life-threatening side effects associated with invasive surgical therapies such as deep brain stimulation and LD/CD intestinal gel.”
Source: Globe Newswire