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Ongentys (opicapone) has been launched in the UK for the treatment of adult Parkinson´s disease patients with motor fluctuations. Opicapone was authorised by the European Commission in June as an adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Several therapeutic strategies are available to improve the signs and symptoms of Parkinson´s disease, mainly dopaminergic drugs avoiding the degradation or mimicking dopamine physiological effects. Levodopa remains the gold-standard treatment for the disease, although its long-term use causes motor complications, like end-of-dose motor complications or wearing-off. ‘Wearing-off’ episodes may be improved with appropriate changes in the medication regimen, such as adding an extra dose of levodopa or using a COMT inhibitor.
The European Commission authorisation for opicapone was based on data from a clinical development programme, which included 28 human pharmacology studies with more than 900 patients exposed to opicapone in 30 countries worldwide. The two pivotal phase III studies, BIPARK-I and BIPARK-II demonstrated that opicapone once-daily achieved an absolute reduction in OFF-time of 103 and 107 minutes respectively and statistically significant increases in ON-time without troublesome dyskinesia compared to placebo.
Opicapone was also associated with significant improvements in both patient and clinician global assessments of change. BIPARK-I was an active-controlled trial and included an entacapone arm: opicapone once-daily demonstrated to be non-inferior to entacapone dosed multiple times per day.
The data from the phase III trials demonstrated that opicapone improves motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors use. It has also been demonstrated to have a generally favourable safety and tolerability profile in the whole trial population and in the subset of patients over 70 years, and is not associated with relevant electrocardiographic or hepatic adverse events.
Both phase III trials included a 1-year open-label extension and opicapone demonstrated an OFF-time reduction from the double-blind phase baseline that was sustained over the open-label phase.
Andrew Lees, Professor of Neurology at the National Hospital for Neurology and Neurosurgery, Queen Square, London and University College London, said: “There is still an unmet medical need for effective new therapeutic options for Parkinson´s disease. Opicapone will provide clinicians in 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.”
António Portela, CEO of BIAL, said: “Studies have shown that Ongentys (opicapone) is an effective, once-daily, an adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. We are pleased that opicapone is now available in UK, a country where BIAL has recently opened an affiliate. Opicapone is the outcome of BIAL’s longstanding scientific commitment to neurological research. These launches also reflect BIAL’s increasing European footprint and the company’s mission to care for the Health of people worldwide.”