On June 29, at the 12th Congress of the European Academy of Neurology (EAN) 2026, NeuroDerm presented post hoc analysis from the pivotal Phase III BouNDless (NCT04006210) study. The presentation highlighted findings supporting Onerji (ND0612), a continuous 24-hour subcutaneous infusion of liquid levodopa and carbidopa (LD/CD), for reducing falls in patients with advanced Parkinson’s disease (PD). In a market where levodopa therapies are becoming increasingly crowded, additional data on fall reduction could help give Onerji a competitive edge.
Falls in patients with advanced PD are often multifactorial, with major contributors including the underlying disease progression, orthostatic hypotension, and dyskinesia that can destabilise gait and balance. Levodopa therapies can also contribute indirectly by causing hallucinations and psychosis in some patients, which can significantly alter a patient’s perception and increase the risk of falls. Key opinion leaders (KOLs) previously interviewed by GlobalData stated that postural instability, gait freezing, and imbalance are unmet needs associated with PD. Addressing falls in PD patients is important because they drive injury, loss of patients’ independence, and caregiver burden, yet marketed products have limited impact on falls in patients with PD.
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In the Phase III BouNDless trial, patients treated with Onerji had lower rates of falls reported as treatment-emergent events (TEAEs) when compared to patients treated with oral immediate release (IR)-LD/CD. The treatment groups had optimized regimens and Onerji was supplemented with oral IR-LD/CD. During the poster session “Movement Disorders 7”, NeuroDerm shared analysis of additional factors associated with falls. The post hoc analysis involved 598 patients of which 113 (18.9%) had reported at least one fall over 1,045 patient-years of treatment, including 45 patients with recurrent falls. When compared with the overall cohort, patients with recurrent falls were older, had been diagnosed with PD for a longer time, and had worse motor severity scores.
Patients that were treated with the optimized Onerji regimen had improved overall postural instability and gait disorder (PIGD) scores, reduced functional impact of freezing, and reduced freezing of gait compared to patients that receive IR-LD/CD. In addition, the patients treated with Onerji had improved cognitive scores and lower rates of troublesome dyskinesia than patients treated with IR-LD/CD. Furthermore, the incidence of orthostatic hypotension reported as a TEAE with Onerji was comparable to IR-LD/CD, though drops of blood pressure of ≥20mm Hg, or of diastolic blood pressure of ≥10mm Hg, were observed less frequently in Onerji-treated patients. The post hoc findings suggests that Onerji supplemented with oral IR-LD/CD has positive effects on the various factors associated with falls. The presenter reported that the reduction in falls may reflect less time spent in OFF time, less severe quality of OFF time, and the benefits of more consistent ON time, associated with continuous LD delivery with Onerji.
To confirm whether the observed signal from the BouNDless post hoc finding translates into robust and clinically meaningful benefit on falls, additional prospective clinical studies are required. In addition, measures of hallucination and psychosis rates could also be considered, as these can contribute to falls in patients with PD. Onerji competes with AbbVie’s continuous 24-hour subcutaneous device, Produodopa/Vyalev (foscarbidopa + foslevodopa). While patients treated with Produodopa had lower rates of falls reported as TEAEs than patients treated with oral LD/CD in its pivotal Phase III trial (NCT04380142), reduction of falls was not a clinical endpoint of the trial. If either Produodopa or Onerji shows a meaningful reduction of falls in large clinical trials where falls are the primary endpoint, that could address an unmet need and serve as a key differentiator between the two competing drugs.
