Opicapone is a catechol-O-methyltransferase (COMT) inhibitor marketed in several countries by either Amneal Pharmaceuticals or Bial, depending on region, under the brand name “Ongentys” for the treatment of levodopa wear-off in Parkinson’s disease (PD). At the 10th Congress of the European Academy of Neurology (EAN) 2024, Dr. Maria-Rosario Luquin and Dr. Lydia López Manzanares separately presented results from observational studies on opicapone treatment in Spanish movement disorder units. Opicapone significantly reduced motor and non-motor fluctuations in patients, including patients with early motor fluctuations. The results confirm that opicapone retains the efficacy and tolerability seen in clinical trials during real-world clinical practice, according to GlobalData, a leading data and analytics company.
Lorraine Palmer, Pharma Analyst at GlobalData, comments: “COMT inhibitors are traditionally prescribed as an adjunct to first-line therapy with levodopa, a precursor to dopamine. Since COMT inhibitors target enzymes that break down dopamine, they extend levodopa’s bioavailability and reduce wear-off episodes. This effect has previously been seen with opicapone in Phase III trials such as BIPARK-I and II.”
Dr. Maria-Rosario Luquin presented the results of the 12-month observational, retrospective study OPTIMO, while Dr. Lydia López Manzanares presented the 3-month interim results from the ongoing REONPARK observational study. The OPTIMO aimed to confirm the efficacy and tolerability of opicapone in the real-world. Treatment with opicapone reduced the percentage of patients with levodopa wear-off, including extending “on” time and reducing non-motor fluctuations.
Likewise, the results from the first three-months of the REONPARK study show opicapone decreasing most wear-off symptoms (both motor and non-motor), with the exception of anxiety and pain. However, the REONPARK study focused specifically on patients with early motor fluctuations (i.e., patients for whom symptoms of wear-off emerged within the last two years), and the interim results presented data from 70 patients.
Palmer continues: “The interim results of the REONPARK study included global impressions of change. In the patient global impression of change, 62.9% of patients reported measurable improvement in their condition. This means that patients experienced an improvement not only in PD motor symptoms but also in motor complications such as wear-off.”
According to GlobalData’s Parkinson’s disease market forecast and analysis to 2029, opicapone is set to experience sizable growth across the seven major markets (7MM), with sales reaching $118.7 million in 2029, registering a compound annual growth rate (CAGR) of 22.9% during 2019-29. In Spain specifically, opicapone sales are forecast to reach $3.8 million in 2029 at a CAGR of 2.3%.
Palmer concludes: “The findings of the real-world studies are in line with the observations of key opinion leaders [KOLs] who, speaking with GlobalData, stated they found opicapone to be efficacious in their practice, with some even stating that they use it as their first choice COMT inhibitor. All of which strongly evidence the efficacy of opicapone in a real-world setting.”
*7MM- the US, the UK, Germany, Spain, Italy, France, and Japan
