approvalsWatch: Neurology 290416
US FDA Approvals
The US FDA has approved pimavanserin for the treatment of delusions and hallucinations associated with psychosis in patients with Parkinson’s disease. The atypical antipsychotic was shown to be effective in a 6-week phase III trial published in 2013 involving 199 patients. Patients randomly assigned to pimavanserin had a significant 3.06-point greater reduction in scores on the Parkinson's disease-adapted scale for assessment of positive symptoms than patients assigned to placebo.
European Medicines Agency Approvals
The EMA’s Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorisation for opicapone as an adjunctive treatment in adults with Parkinson’s disease and motor fluctuations. The peripheral, selective and reversible COMT inhibitor is indicated as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors to increase L-DOPA plasma levels in patients who cannot be stabilised with these combinations. It benefits patients by decreasing times of poor response and increasing periods of good response without causing troublesome dyskinesia.