At the 10th Congress of the European Academy of Neurology (EAN) 2024, three papers were presented on the efficacy of safinamide as an add-on therapy to levodopa for the treatment of Parkinson’s disease (PD): a post-hoc analysis of two safinamide trials, a pharmacoeconomic report comparing safinamide and rasagiline, and a retrospective observation study of patients in a Spanish movement disorder unit comparing safinamide to opicapone.
The data presented showed that safinamide treatment led to clinically significant improvements in PD symptoms irrespective of patient gender despite differences between sexes in the clinical manifestation of PD. Safinamide has a higher patient response rate against placebo than rasagiline, but did not appear to lead to any significant differences in patient outcomes compared to opicapone.
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Safinamide is marketed in the US and nine European countries under the brand name Xadago, for the treatment of PD as an adjunct to levodopa (a dopamine precursor). It is a monoamine oxidase B (MAO-B) inhibitor that also has a dopaminergic mechanism of action. Most adjunct therapies in the PD market are designed to prolong the duration of levodopa’s half-life in the blood. Traditionally, oral MAO-B inhibitors and catechol-O-methyltransferase (COMT) inhibitors, which inhibit enzymes that break down dopamine, are prescribed to allow dopamine to circulate in the body longer. Given its mechanism and clinical positioning, safinamide is not only in competition with rasagiline, another MAO-B inhibitor, but also with opicapone, a COMT inhibitor.
Studies have explored gender differences in anti-PD drug response
Dr. Carlo Cattaneo presented a post-hoc analysis of the SYNAPSES trial (an observational, European, multicentre, retrospective-prospective cohort study with 1,610 participants) and the XINDI trial (NCT03881371, a Chinese Phase III, randomised, double-blind, placebo-controlled, multicentre trial with 307 participants). The post-hoc analysis aimed to investigate the effects of safinamide on PD patients according to gender, as there are limited published studies exploring differences between sexes in response to anti-PD drugs. Both trials contained patients with fluctuating PD and safinamide was administered as an add-on to levodopa.
Motor complications, motor symptoms and quality of life were then measured using the Unified Parkinson’s Disease Rating Scale (UPDRS). The post-hoc analysis found that clinically significant improvements in UPDRS total scores with safinamide occurred at a higher rate in men than women, with 43.5% of men reporting clinically significant total scores to 39.1% of women. However, this difference was not found to be statistically significant. It was concluded that safinamide provided effective treatment for both sexes, which suggests that it is a competitive choice regardless of the patient’s sex and the potentially differing PD symptom profile.
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Dr. Ester Morales García presented a pharmacoeconomic report comparing safinamide to its competitor rasagiline, drawing from systematic reviews and meta-analyses that themselves compared either safinamide or rasagiline to a placebo and were published before September 2023. The pharmacoeconomic analysis found that safinamide performed better than rasagiline in terms of efficacy, safety and cost-efficacy. In all cases evaluated across 49 studies included in the meta-analysis, safinamide was superior to rasagiline in terms of the ratio of responsive patients to non-responsive patients. These findings are in line with the anecdotal observations of key opinion leaders (KOLs) interviewed by GlobalData for the Parkinson’s Disease – Seven Market Drug Forecast and Market Analysis to 2029 report.
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By GlobalDataShifting dynamics in the treatment of PD
KOLs stated that patients on Xadago showed superior improvements in comparison to patients on Azilect (rasagiline). However, both the pharmacoeconomic analysis and KOLs agreed that in situations where the treatment budget is restrictive, rasagiline remains a competitive choice due to its lower price.
Lastly, when comparing safinamide and opicapone (marketed under the brand names Ongentys and Ontilyv) as adjuncts to levodopa in patients with motor fluctuations (patients who experience episodes of wear-off with levodopa), the retrospective observation study of 89 patients presented by Dr. Pablo Lorenzo Barreto found no significant difference between either drug in patient outcomes as measured through new-onset or worsening dyskinesia and discontinuation rates. However, treatment with opicapone appeared to facilitate greater levodopa dose reduction, with 10% of patients on opicapone undergoing levodopa dose reduction in contrast to 0% of patients on safinamide, although this observation would need to be confirmed in studies with a greater sample number.
Combined, these three presentations lend credence to GlobalData’s Parkinson’s Disease – Seven Market Drug Forecast and Market Analysis to 2029 report, which forecasts that Ongentys (opicapone) will outcompete Xadago (safinamide) in the seven major markets (France, Germany, Italy, Japan, Spain, the UK and the US). Both were expected to experience growth, however Xadago’s 2029 sales are forecast at $71.6 million, while Ongentys is forecast to reach 2029 sales of $118.7 million, with compound annual growth rates (CAGRs) of 5.1% and 22.9%, respectively. Azilect is expected to experience a decline, reaching sales of $75.8 million in 2029 with a negative CAGR of 0.8%. 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 safinamide, opicapone and rasagiline.
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