EU CHMP recommends approval of Ongentys (opicapone) for Parkinson's Disease- Bial

The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ongentys (opicapone), from Bial, indicated as adjunctive therapy in adult patients with Parkinson�s disease and motor fluctuations. Ongentys will be available as hard capsules (25 mg and 50 mg).

The active substance of Ongentys is opicapone, a peripheral, selective and reversible COMT inhibitor (ATC code: N04) that increases L-DOPA plasma levels when used concomitantly with L-DOPA/DOPA-decarboxylase inhibitors (DDCIs). The benefits with Ongentys are its ability to decrease off-time (time when patients are severely restricted by their symptoms) and to increase on-time without troublesome dyskinesia. The most common side effects are dyskinesia, constipation, insomnia, dry mouth and dizziness.