Patients with Parkinson's disease in the UK can now potentially access a new option to treat motor fluctuations with the launch of Bial's Ongentys across the country.
Ongentys (opicapone) was authorised by European regulators in June as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with the disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Levodopa remains the gold-standard treatment for the disease, although its long-term use causes what is known as motor complications, like end of dose motor complications or wearing-off. Wearing-off episodes may be improved by altering the medication regimen, by adding an extra dose of levodopa or using a COMT inhibitor such as Ongentys, for example.
"There is still an unmet medical need for effective new therapeutic options for Parkinson´s disease," noted Andrew Lees, Professor of Neurology at the National Hospital for Neurology and Neurosurgery, Queen Square, London and University College London. "Opicapone will provide clinicians in the UK with a COMT inhibitor, with the convenience of once-daily dosing. It is an option when levodopa-treated patients need additional help to improve motor symptoms such as wearing off in Parkinson's disease."
Approval of the drug was based on data from a clinical development programme which exposed more than 900 patients to Ongentys in 30 countries.
The two pivotal Phase III studies, BIPARK-I and BIPARK-II, showed that a once-daily dose of the drug achieved an absolute reduction in OFF-time (time when patients are severely restricted by their symptoms) of 103 and 107 minutes, respectively, and statistically significant increases in ON-time without troublesome dyskinesia versus placebo.
Parkinson's disease is a neurodegenerative, chronic and progressive disease, estimated to affect 1.2 million people in the European Union, with around 260,000 in Germany and 120,000 in UK.