Safety and Efficacy of Opicapone for Patients With Parkinson’s Disease
Safety and efficacy results for opicapone (Neurocrine Biosciences, San Diego, CA), an investigational treatment for end-of-dose motor symptoms, termed off-time, in patients with Parkinson’s disease (PD), are being presented at the 2018 World Congress on Parkinson's Disease and Related Disorders (IAPRD) in Lyon, France, Aug. 19-22, 2018.
In BIPARK I study (NCT01568073), patients treated with opicapone, a 3rdgeneration catechol-o-methyltransferase (COMT) inhibitor, had reduced off-time (Lancet Neurology:2016;15(2):154-164.). During the BIPARK I study 63.8% to 72% of patients treated with opicapone had positive global impression of compared to 52.5% for those treated with entacapone and 50% for those treated with placebo.
In a 1-year open-label extension of the study, 423 patients diagnosed with idiopathic PD at least 3 years before the trial began, receiving levodopa for at least 1 year, and having off-time of more than 1.5 hours per day were given 5 mg, 25 mg, or 50 mg of opicapone per day according to the patient’s clinical response. Patients who had received entacapone or placebo during the trial were switched to opicapone. All patients had significant reductions in off-time while on opicapone and the efficacy was maintained for over 1 year.
"Neurocrine Biosciences is committed to bringing innovative and effective treatments to patients living with movement disorders," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. We believe these results will help healthcare providers further understand the benefits of Ingrezza and the potential of opicapone to help patients suffering from these serious, and often isolating, movement disorders."