Ongentys (opicapone) / Fosun Pharma, Ono Pharma, Neurocrine, SK Bio, BIAL - LARVOL DELTA

Opicapone for nocturnal hypokinesia in patients with Parkinson's disease: An open-label pilot clinical trial. (PubMed, J Mov Disord) - "Administration of opicapone in patients with PD and NH did not demonstrate a significant improvement in NH, although it was associated with an improvement in the single domain of getting out of bed. Further studies are needed to establish the efficacy of opicapone for NH."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Nocturnal Hypokinesia and Early Morning OFF in Parkinson's Disease: State-of-the-Art and Systematic Review of Treatment Availability. (PubMed, Curr Neurol Neurosci Rep) - "Pharmacologic treatments include standard and sustained-release levodopa, dopamine agonists (rotigotine, ropinirol, pramipexole, and apomorphine), MAO-B inhibitors (rasagiline, safinamide), COMT inhibitors (opicapone), and rescue therapies like inhaled or dispersible levodopa or apomorphine injection. For mild, disturbing symptoms in early PD, inhaled or dispersible levodopa or apomorphine injection are advised. In moderate to advanced stages, treatment options include long-acting dopamine agonists, MAO-B inhibitors, sustained-release levodopa, or COMT inhibitors selected based on factors such as daytime motor symptoms, and non-motor symptoms."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Safety of COMT-inhibitors in parkinson's disease: a phase-IV comparative study on adverse events of Tolcapone, Entacapone and Opicapone. (PubMed, J Neural Transm (Vienna)) - "Entacapone appears to be the safest long-term COMT-inhibitor, with the lowest risk of both serious and non-serious AEs. A long-term, prospective clinical trial is warranted to overcome retrospective limitations and confirm these findings."

Adverse events • Journal • P4 data • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Real-world safety profile of opicapone: a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This study underscores the necessity of robust post-marketing surveillance to monitor the safety of opicapone in real-world settings. Our findings contribute novel insights into its AE profile and highlight potential risks associated with its concomitant use with levodopa/carbidopa, providing valuable evidence to guide clinical decision-making and risk mitigation strategies."

Adverse events • Journal • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypotension • Movement Disorders • Ophthalmology • Parkinson's Disease • COMT

Treatment Stability Across Different ADD-ON Therapies in Fluctuating Parkinson's Disease (MDS Congress 2025) - "Objective: This study investigates the efficacy and tolerability of selegiline (SL), rasagiline (RS), safinamide (SF), and opicapone (OP) in fluctuating PD patients, focusing on treatment stability and demographic influences. No single add-on therapy demonstrated superior stability, highlighting comparable efficacy across options. Sex significantly influenced therapy adjustments, with females requiring more frequent modifications. These findings underscore the importance of personalized treatment strategies in fluctuating PD management."

CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Opicapone for OFF Motor Fluctuations in Parkinson's Disease: A Systematic Review and Meta-Analysis of Randomized Trials (MDS Congress 2025) - "Opicapone 50 mg demonstrated a modest but significant improvement in motor function and a clinically meaningful reduction in OFF time in PD patients with motor fluctuations. These findings support its use as an effective adjunct therapy in PD. Further studies are warranted to explore long-term efficacy and real-world effectiveness."

Retrospective data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Risk of Motor Complications in Early Parkinson's Disease Patients Treated with Opicapone in the EPSILON study: Effect of Levodopa Dose (MDS Congress 2025) - "Although most patients remain free of MCs with early OPC use, this exploratory analysis reports a trend towards higher risk of MC in those with higher levodopa doses (≥400mg/day) who started OPC later. While further research is needed, early OPC introduction may promote motor stability even in patients on higher levodopa doses. Figure 1"

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Opicapone improves end-of-dose neuropsychiatric fluctuations in patients with Parkinson's disease (MDS Congress 2025) - "OPC improved end-of-dose fluctuations in anxiety, depression, and executive functions/attention, while memory and visuospatial abilities showed no significant changes. TABLE 3B TABLE 3A TABLE 2 TABLE 1 TABLE 4"

Clinical • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • COMT

Opicapone in Parkinson's Patients with Probable REM Sleep Behavior Disorder: Insights from the OASIS Trial (MDS Congress 2025) - "Adding opicapone 50 mg to levodopa in patients with PD, motor fluctuations and sleep disturbances improved sleep complaints to a similar extent in those with and without probable RBD, although the analysis is limited by low patient numbers. Figure 1 Table 1"

Clinical • Behavior Disorders • CNS Disorders • Dystonia • Mental Retardation • Movement Disorders • Parkinson's Disease • Psychiatry • REM Sleep Behavior Disorder • Sleep Disorder

Safety and tolerability of overnight switching from Eetacapone to Opicapone in fluctuating Parkinson's disease: An open-label preliminary trial in Koreans (MDS Congress 2025) - "An overnight switching of entacapone to opicapone is safe and well tolerated. The majority of subjects preferred opicapone due to reducing off time with peak dose dyskinesia and the convenience."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Safety Profile of Opicapone in Elderly and Very Elderly Population (MDS Congress 2025) - "Our analysis confirms a generally good safety profile in elderly patients, with no major differences in very elderly population. Most AEs were non-serious and the most reported were considered expected. This suggests that OPC maintains an adequate safety profile in real-world elderly patients."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Long-Term Effect of Opicapone in Parkinson's Patients Without Motor Complications: 1.5-year EPSILON Study Findings (MDS Congress 2025) - P3 | "Opicapone provided sustained symptomatic relief over 1.5 years in levodopa-treated patients without motor fluctuations and was not associated with an increased risk for motor complications. Figure 1 Figure 2"

Clinical • CNS Disorders • Dystonia • Movement Disorders • Parkinson's Disease

Effect of Opicapone on Sleep-Related Complaints and Non-Motor Burden in Parkinson's Patients: A Post-Hoc Analysis of the OASIS Trial (MDS Congress 2025) - "Add-on OPC improved sleep-related symptoms by >30%, including insomnia and restorative sleep, while alleviating nighttime and morning motor symptoms. It significantly reduced NMS burden, particularly sleep disturbances and daytime sleepiness, indicating its potential to address both motor and non-motor challenges in PD patients with wearing-off, sleep-related disturbances and high NMS burden. Figure 1 Table 1"

Clinical • Retrospective data • CNS Disorders • Depression • Insomnia • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

Comparative Efficacy and Safety of Opicapone in Parkinson's Disease: An Updated Systematic Review and Meta-Analysis (MDS Congress 2025) - "This study states Opicapone's efficacy in reducing OFF episodes and increasing ON time without worsening dyskinesia. No significant improvement found in UPDRS-III scores. Its tolerability remains acceptable, but further research is required to optimize its role in PD treatment."

Retrospective data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Effectiveness of Opicapone Added to Different Levodopa Doses and LEDDs in Parkinson's Disease: Post-Hoc Analysis of the ADOPTION Trials (MDS Congress 2025) - "Opicapone consistently reduced OFF-time by ~1 hour independently from the total levodopa dose or LEDD at baseline, and was more efficacious than an increased levodopa dose, suggesting that it is an effective strategy for managing early motor fluctuations in PD patients. Figure 1"

Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

COMT-Inhibitors Clinical Experience In Early Motor Fluctuations. Six Months Analysis Of REONPARK Study (MDS Congress 2025) - " One hundred and thirty-one evaluable patients (mean±SD: 65.2±10 years old; 5.1±3.2 years PD duration; 472.9±196 mg/daily L-dopa/DDCI; MDS-UPDRS III:22.5±14.3; MDS-UPDRS IV:2.9±2.1) initiated COMTi (99.3% opicapone; 0.7% entacapone). COMTi (mainly opicapone) treatment demonstrated a reduction on OFF time and motor complications, improving the functional impact of fluctuations after 6 months of treatment in real-world practice. Table 1 Figure 1 Figure 2"

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

COMT-Inhibitors Clinical Experience In Early Motor Fluctuations. Three Months Analysis Of REONPARK Study (MDS Congress 2025) - "Presenting here an interim analysis up to 3 months post COMTi initiation One hundred and thirty-eight evaluable patients (mean±SD: 65.4±10 years old; 5.3±3.5 years PD duration; 474.3±197 mg/daily L-dopa/DDCI; MDS-UPDRS III:23.7±14.4; MDS-UPDRS IV:3.0±2.1) initiated COMTi (99.3% opicapone; 0.7% entacapone). COMTi (mainly opicapone) treatment demonstrated a reduction on OFF time and motor complications, improving the functional impact of fluctuations after 3 months of treatment in real-world practice. Table 1 Figure 1 Figure 2"

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Comparative efficacy of opicapone and entacapone in the management of motor fluctuations in Parkinson's disease (MDS Congress 2025) - "Compared to ENT, OPC provides numerically higher reduction of "Off" time, increased "On" time, and a higher proportion of patients reporting meaningful clinical improvement. The benefit was maintained in the OLE study, further supporting its long-term efficacy. These findings suggest that OPC's once-daily dosing offers an effective and convenient option for optimizing LD therapy in patients with PD."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

OPICAPONE IMPROVES END-OF-DOSE NEUROPSYCHIATRIC FLUCTUATIONS IN PATIENTS WITH PARKINSON'S DISEASE (WCN 2025) - "OPC improved end-of-dose fluctuations in anxiety/depression, and executive functions/attention, while memory and visuospatial abilities showed little or no significant changes."

Clinical • CNS Disorders • Depression • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • COMT

SAFETY AND TOLERABILITY OF OVERNIGHT SWITCHING FROM EETACAPONE TO OPICAPONE IN FLUCTUATING PARKINSON'S DISEASE: AN OPEN-LABEL PRELIMINARY TRIAL IN KOREANS (WCN 2025) - "An overnight switching of entacapone to opicapone is safe and well tolerated. The majority of subjects preferred opicapone due to reducing off time with peak dose dyskinesia and the convenience."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

The Cost-Effectiveness of Opicapone Versus Entacapone as Adjuvant Therapy for Levodopa-Treated Individuals With Parkinson's Disease Experiencing End-of-Dose Motor Fluctuations. (PubMed, Parkinsons Dis) - P3 | " Opicapone is cost-effective when compared with entacapone for levodopa-treated PD patients experiencing end-of-dose motor fluctuations. Trial Registration: ClinicalTrials.gov identifier: NCT01568073."

HEOR • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Effectiveness of opicapone added to different levodopa doses in Parkinson's: Post-Hoc analysis of the ADOPTION trials (EAN 2025) - "Opicapone consistently reduced OFF-time by ~1 h independently from the total levodopa dose at baseline and was more efficacious than an increased levodopa dose, suggesting that it is an effective strategy for early motor fluctuations in PD patients."

Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

Switching from placebo to opicapone in non-fluctuating Parkinson's disease patients: Findings from EPSILON study (EAN 2025) - "OPC provided sustained motor benefits with a higher proportion of patients free of motor complications compared with those initially on placebo. These results support early OPC use in levodopa-treated PD patients without motor fluctuations."

Clinical • CNS Disorders • Dystonia • Movement Disorders • Parkinson's Disease

Long-term effect of opicapone in Parkinson's patients without motor complications: 1.5- Year EPSILON study findings (EAN 2025) - "OPC provided sustained motor benefits over 1.5 years with few patients developing motor complications, supporting its long-term use in PD patients without motor fluctuations."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Effect of opicapone on non-motor burden in people with Parkinson's disease-related sleep disturbances: The OASIS study (EAN 2025) - "OPC significantly reduced NMS burden, particularly improving sleep-related issues, such as insomnia and daytime sleepiness, in PD patients with motor fluctuations and sleep disturbances, highlighting its potential to address both motor and non-motor challenges in this population."

CNS Disorders • Depression • Insomnia • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder