Parkinson’s disease patients in Europe will soon have to access a new treatment option for their disease, after the European Commission (EC) approved the use of Ongentys (opicapone) — developed and marketed by Bial — as an adjunctive therapy for patients with motor fluctuation.
The drug, a third-generation catechol-O-methyltransferase (COMT) inhibitor, is approved as an add-on therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adults with Parkinson’s, whose end-of-dose motor fluctuations fail to stabilize on those medications.
“Opicapone is a new treatment option and fulfils the need for a more potent COMT inhibitor, offering an important alternative to the currently available armamentarium for the treatment of motor fluctuations,” Joaquim Ferreira, a professor of Neurology and Clinical Pharmacology at the University of Lisbon, said in a company press release.
Professor Heinz Reichmann, with the Department of Neurology at the University of Dresden and dean of its medical faculty, added that opicapone “may become the treatment of choice when levodopa-treated patients need additional help to improve motor symptoms such as wearing off in Parkinson’s disease.”
Levodopa is considered the gold-standard treatment for Parkinson’s, although its long-term use can be accompanied by motor complications, like end-of-dose or wearing-off fluctuations, leading to progressively shorter intervals in which symptoms are adequately controlled.
Two pivotal Phase 3 clinical trials, BIPARK-I and BIPARK-II, were critical to Ongentys’ regulatory approval. Data resulting from the studies showed that the drug in levodopa-treated patients achieved an absolute reduction in “off” time of two hours without increasing “on” time with dyskinesia (involuntary muscle movements). An additional one-year extension study also demonstrated the sustainability of this effect. (“Off” time refers to periods when a medicine’s effectiveness is low and disease symptoms are worsening.)
“We are very pleased to achieve this major regulatory milestone for ONGENTYS®, which offers patients living with Parkinson’s disease an effective, once-daily, adjunctive treatment option,” said António Portela, Bial’s chief executive officer.
Bial expects to make Ongentys available to patients across the European Union beginning this year and through 2017. The European Parkinson’s Disease Association (EPDA) estimates that 1.2 million people with Parkinson’s are living in EU countries.