Levodopa oral inhalation powder

The standard of care for Parkinson’s disease is oral levodopa plus a dopa-decarboxylase inhibitor (LD-DCI). However, about half of the patients develop debilitating OFF episodes within 5 years of starting treatment. For the treatment during such OFF periods, a self-administered levodopa inhalation powder in development for the treatment of OFF symptoms called CVT-301 was successfully evaluated.

The extension of the SPAN-PD trial showed that CVT-301 maintained its efficacy over 12 months in achieving an ON state in patients experiencing OFF periods, and showed improved efficacy in decreasing daily OFF time and increasing ON time without dyskinesia [1]. During the initial 12-week, double-blind phase, CVT-301 84 mg was associated with significant improvements in Unified Parkinson Disease Rating Scale (UPDRS) motor scores at 30 minutes post-dosing compared to placebo (-9.83 vs -5.91). In addition, 57.7% of patients on CVT-301 84 mg turned ON within 60 minutes after treatment vs 36.1% on placebo [2].

In the extension study, patients from the SPAN-PD study and eligible CVT-301-naïve patients were enrolled. They maintained their usual oral carbidopa/levodopa regimen. All patients were on CVT-301 treatment for OFF periods, but were blinded to dose: 60 mg (n=161) or 84 mg (n=164). At 12 months, 68.4% and 73.0% of patients on CVT-301 60 mg and 84 mg, respectively, achieved an ON state within 60 minutes. These percentages were not significantly different from 1-month values, suggesting that treatment efficacy was maintained. Mean changes in total daily OFF time improved from –0.33 and –0.55 hours at 1 month, to –0.70 and –0.88 hours at 12 months for 60 mg and 84 mg, respectively. Change from baseline in daily ON time without dyskinesia improved from +0.23 and +0.18 hours at 1 month, to +0.32 and +0.40 hours at 12 months.

1. Farbman ES, et al. AAN 2019, P2.8-048.
2. LeWitt PA, et al. Lancet Neurol. 2019;18(2):145-54.



Posted on 30 July 201917 May 2024