FDA proposes overhaul of perioperative lung cancer trial of Opicapone

At the 10th Congress of the European Academy of Neurology (EAN) in 2024, two posters on real-life clinical experience with Opicapone in the treatment of motor fluctuations in Parkinson's disease (PD) were presented. Both posters present the results of an observational study conducted in a Spanish Movement Disorders Unit. Opicapone was shown to significantly reduce motor and non-motor fluctuations in patients. This includes patients with early motor fluctuations, such as those who have experienced symptoms of levodopa withdrawal for up to two years.

Opicapone is marketed byAmneal Pharmaceuticals or Bial in several countries, including the United States and nine European countries, depending on the region. It is a catechol-O-methyltransferase (COMT) inhibitor traditionally used as an adjunct to levodopa, the first-line treatment for Parkinson's disease and a precursor to dopamine. COMT inhibitors inhibit the enzyme that breaks down dopamine, thereby prolonging the bioavailability of levodopa. This reduces episodes of wear and tear, as previously seen with opicapone in the Phase 3 trials BIPARK-I (NCT01568073) and II (NCT01227655).

InEAN, results from the 12-month observational retrospective OPTIMO study are presented. The study aimed to confirm the efficacy and tolerability of opicapone in real-world settings by evaluating its clinical performance in a Spanish movement disorders unit. The study was conducted in 16 Spanish health centers and enrolled 245 patients, all of whom were taking levodopa. Patients were prescribed adjuvant Opicapone as part of their treatment, and clinical data were collected at baseline, 3 months, and 7 months after treatment initiation.

Treatment with opicapone has been shown to reduce the percentage of patients with levodopa failure, including prolonging "on" time and reducing non-motor fluctuations. Daily "off" time was significantly reduced from 143 to 67.9 minutes, and 74.2% of patients described improvement in motor fluctuations. The results confirm that in real-world clinical practice, opicapone retains the efficacy and tolerability observed in clinical trials.

Also, withUnlike the OPTIMO study, the REONPARK study was designed to evaluate COMT inhibitors more broadly, but the results presented at EAN focused on opicapone. Similar to OPTIMO, REONPARK is a Spanish observational study designed to evaluate the efficacy and tolerability of COMT inhibitors in real-world practice. REONPARK, however, focuses on patients with early-stage motor fluctuations, such as those who have developed wear-and-tear symptoms within the past two years. The poster presents an interim analysis of the first three months of the study, in which data from 70 patients were analyzed.

Interim results show that after three months of Opicapone treatment, most fatigue symptoms (exercise and non-exercise) were reduced, except for anxiety and pain. Based on patient and clinical overall impression of change, 62.9% of patients and 73.5% of patients improved, respectively.

The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) mean scores improved by -3.3 and -1.3, respectively, for Part III (motor symptoms of PD) and Part IV (measurement of motor complications). The total MDS-UPDRS score improved by -5.7 points on average. This suggests that, at least in the first three months of the study, opicapone has proven effective in controlling motor symptoms in PD patients with early motor fluctuations.