At the 10th Congress of the European Academy of Neurology (EAN) 2024, two posters were presented on the real-world clinical experience of opicapone for the treatment of motor fluctuations in Parkinson’s disease (PD). Both posters presented the results from observational studies carried out in movement disorder units in Spain. Opicapone was confirmed to significantly reduce motor and non-motor fluctuations in patients. This includes patients with early motor fluctuations, such as patients who have been experiencing levodopa wear-off symptoms for up to two years.
Opicapone is marketed in several countries, including the US and nine European countries, as Ongentys by either Amneal Pharmaceuticals or Bial depending on the region. It is a catechol-O-methyltransferase (COMT) inhibitor traditionally prescribed as an adjunct therapy to levodopa, a first-line therapy for the treatment of PD and a precursor to dopamine. COMT inhibitors inhibit enzymes that break down dopamine, thereby extending levodopa’s bioavailability. This reduces wear off-episodes, as has previously been seen with opicapone in the Phase III trials, BIPARK-I (NCT01568073) and II (NCT01227655).
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At EAN, Dr Maria-Rosario Luquin presented the results of the 12-month, observational, retrospective OPTIMO study. The study aimed to confirm the efficacy and tolerability of opicapone in the real world by evaluating its clinical performance in Spanish movement disorder units. It was conducted in 16 Spanish health centres and enrolled 245 patients, all of whom were on levodopa. The patients were prescribed adjunct opicapone as part of their treatment, with clinical data being collected at baseline, at three months, and at seven months post-treatment initiation. Treatment with opicapone was confirmed to reduce the percentage of patients with levodopa wear-off, including extending “on” time and reducing non-motor fluctuations. Daily “off” time was significantly reduced from 143 minutes to 67.9 minutes, and 74.2% of patients described improvements in motor fluctuations. The results confirmed that opicapone retained the efficacy and tolerability seen in clinical trials during real-world clinical practice.
Additionally, interim results from the REONPARK study were also presented in a different poster session by Dr Lydia López Manzanares. Unlike the OPTIMO study, the REONPARK study aims to evaluate COMT inhibitors more broadly, but the results presented at EAN focused on opicapone. Similar to OPTIMO, REONPARK is a Spanish observational study aiming to evaluate the efficacy and tolerability of COMT inhibitors in real-world practice. However, REONPARK focuses on patients with early motor fluctuations, such as patients who have symptoms of wear-off that emerged within the last two years. The poster presented an interim analysis of the first three months of the study, wherein data from 70 patients was analysed. The interim results show that after three months of opicapone treatment, most wear-off symptoms (both motor and non-motor) had decreased, except anxiety and pain. According to the patient and the clinical global impression of change, 62.9% of patients and 73.5% of patients, respectively, experienced a measured improvement in patient condition. Mean scores for both the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts III (PD motor symptoms) and IV (measuring motor complications) improved by -3.3 and -1.3, respectively. Total MDS-UPDRS scores improved by a mean of -5.7. This showed that at least for the first three months of the study, opicapone has demonstrated effective control of motor symptoms in PD patients with early motor fluctuations.
These findings are in line with the observations of key opinion leaders (KOLs) interviewed for GlobalData’s Parkinson’s Disease – Seven Market Drug Forecast and Market Analysis to 2029 report. KOLs found opicapone to be efficacious, with some even stating that they use it as their first choice COMT inhibitor. GlobalData forecasts Ongentys to experience growth, reaching sales of $118.7m across the seven major markets (US, France, Germany, Italy, Spain, the UK, and Japan) by 2029, at a compound annual growth rate (CAGRs) of 22.9%. More specifically, GlobalData forecasts that Ongentys will have sales of $3.8m in 2029 in Spain, at a CAGR of 2.3%. GlobalData’s upcoming Parkinson’s Disease – Seven Market Drug Forecast and Market Analysis to 2033 report will re-examine the shifting dynamics in the treatment of PD, including the sales forecasts for opicapone in the Spanish market.
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