ARTICLE | Clinical News

Safinamide regulatory update

January 5, 2015 8:00 AM UTC

Newron and partner Zambon announced the resubmission of an NDA to FDA for safinamide to treat Parkinson’s disease. The application covers the use of safinamide as an add-on therapy to a stable dose of a single dopamine agonist for patients with early PD and as an add-on therapy to levodopa alone or in combination with other PD treatments in patients with mid- to late-stage PD. FDA had issued a refusal to file letter after the first NDA submission last May. The partners said the letter was based on organizational and navigational problems with the submission. ...