BioCentury
ARTICLE | Clinical News

ND0612H regulatory update

May 18, 2015 7:00 AM UTC

FDA lifted a clinical hold on NeuroDerm’s ND0612H and ND0612L to treat Parkinson’s disease. The company plans to begin U.S. clinical trials next half. NeuroDerm said FDA placed the hold in June 2014 seeking additional information on the “accuracy, safety and compatibility” of the delivery device. ND0612H and ND0612L are high and low-dose formulations of liquid levodopa and carbidopa delivered continuously via a subcutaneous belt pump.

NeuroDerm said the agency lifted the hold after reviewing results from a compatibility study and other information submitted by the company. NeuroDerm did not respond to inquiries about the compatibility study or its upcoming trials. ...