MONITORING FORCE files for Flibanserin orphan drug status designation with the EMEA

Nov 19 2009

MONITORING FORCE GmbH announced that they have filed on November 16th, 2009 Flibanserin in the indication treatment-relevant levodopa-induced dyskinesia in Parkinson's disease for orphan drug status designation with the European Medicines Agency (EMEA). Levodopa-induced dyskinesia is a complication of the mainstay treatment in advanced Parkinson's and a serious burden to some of those affected, since it may be disabling for the patients and preventing them from receiving optimal treatment for Parkinson's.

Flibanserin is a 5-HT1a agonist and a 5-HT2a antagonist and thus fits in with the current theory on levodopa-induced dysinesia that dyskinesia is caused by the release of dopamine from serotonergic neurons. MONITORING FORCE is preparing to file another orphan drug status application with the United States Food and Drug Administration (FDA) and expects the first clinical trial in Parkinson's patients to start by mid-2010.