Post hoc analyses presented at the Movement Disorder Society's Virtual Congress 2020 September 12-16 showed once-daily opicapone (Ongentys; Neurocrine Biosciences, San Diego, CA) decreased off time’ and increased on time without troublesome dyskinesia in Parkinson disease (PD). Opicapone was approved for treatment of motor fluctuations of PD in April 2020 and is an adjunctive treatment used with levodopa/carbidopa for treatment of PD.
In phase 3 studies, treatment with 50 mg of opicapone (n=57) reduced off time in by 109.2 minutes vs 40.3 minutes with placebo treatment (n=67; P=.0161).
Now, in an independent post-hoc analysis of data from the phase 3 studies, there is evidence that, when used as the first adjunctive COMT bidopa in people with PD recently diagnosed with motor fluctuations, opicapone significantly increased absolute on time by 124 minutes (n=40), which is approximately 1 hour more than the 60 minutes experienced with entacapone (n=47; P=.0344).
"These data analyses demonstrated the benefit of adding once-daily Ongentys to levodopa/carbidopa earlier in the treatment regimen of patients with Parkinson disease. In addition to decreasing off time, the data also show that Ongentys significantly increased on time, compared to an older COMT inhibitor, to help control motor fluctuations in patients with PD," said Eiry W. Roberts, MD, chief medical officer, Neurocrine Biosciences. "We are looking forward to bringing Ongentys to patients as a new add-on treatment option as data from our real-world study show that the debilitating symptoms of Parkinson disease result in more hospitalizations and emergency room visits, impacting the healthcare system in the US."
The studies involved, Bipark-1 (NCT01568073) and Bipark-2 (NCT01227655), were phase 3 randomized double-blind placebo and active-controlled studies of opicapone. Bipark-1 assessed opicapone as an adjunct to levodopa therapy in which 600 participants with PD and motor fluctuations received once-daily doses of opicapone (5 mg, 25 mg, or 50 mg), placebo, or 200 mg doses of the COMT inhibitor entacapone for 14 to 15 weeks. BIPARK-2 assessed opicapone as an adjunct to levodopa therapy in which 400 participants with PD and motor fluctuations received once-daily doses of opicapone (25 mg or 50 mg) or placebo for 14 to 15 weeks.
The most common adverse events are falling asleep during daily activities, dizziness, dyskinesia, hallucinations and delusions, and unusual urges.
Barbara C. Jobst, MD
Zehra Farzal, MD; Guillaume Lamotte MD, MSc; Elizabeth Mundel, MD; Laxman B. Bahroo, DO; and Fernando L. Pagan, MD