Neurocrine Biosciences Receives Guidance from Food and Drug Administration for New Drug Application for Opicapone as Adjunct Therapy to Levodopa in Parkinson's Disease
Opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase (COMT) inhibitor that prolongs the effect of levodopa by decreasing the rate of conversion to 3-O-methyldopa, reducing off-time and extending on-time of levodopa without the same side-effects and complicated dosing regimen of other COMT inhibitors.
Opicapone was approved in the European Union (EU) as Ongentys for adjunct 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 stabilized on those combinations. That approval was based on a clinical development program of 28 studies in 30 countries that included an aggregate of over 900 patients treated with opicapone. In the US and Canada, opicapone is an investigational drug, not approved for use.
Based on pivotal data utilized for approval in the EU, the Neurology Division of the FDA has not requested that Neurocrine conduct an additional phase 3 prior to the NDA filing, paving the way for Neurocrine to proceed with plans to file the NDA for opicapone during the first half of 2019.
Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine said, "we had a very productive meeting with the FDA and are pleased that we can proceed with the NDA submission based on the robust clinical data that already exists for opicapone."
The 2 pivotal phase 3 studies utilized for EU approval showed that taking opicapone once-daily achieved a statistically significant decrease in off-time periods for Parkinson's patients compared to placebo and entacapone, another COMT. Opicapone was associated with significant improvements in both patient and clinician global assessments of change and improved motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors used. Opicapone was generally well tolerated and was not associated with relevant electrocardiographic or hepatic adverse events.