August 8th 2024: The US Food and Drug Administration (FDA) has granted approval to Amneal Pharmaceuticals‘ CREXONT (carbidopa/levodopa) extended-release capsules for the treatment of Parkinson’s disease. This novel oral formulation combines immediate-release granules and extended-release pellets, meaning that therapeutic levels of levodopa and carbidopa may be maintained with less frequent dosing to maximise “good on” time, defined as time without troublesome dyskinesia.
Clinical Efficacy
In the pivotal RISE-PD phase III clinical trial, CREXONT demonstrated statistically significant improvements in “Good On” time compared to immediate-release CD/LD. Specifically:
- Patients experienced an additional 0.5 hours of “Good On” time per day
- CREXONT required only three daily doses versus five for immediate-release CD/LD
- Post-hoc analysis revealed 1.6 hours of additional “Good On” time per dose of CREXONT
Pharmacological Profile
CREXONT’s formulation differs from RYTARY, another extended-release CD/LD product. The innovative combination of immediate-release granules and extended-release pellets aims to provide:
- Rapid onset of action
- Prolonged duration of effect
- More consistent plasma levodopa levels
Safety and Tolerability
The safety profile of CREXONT was consistent with that of immediate-release CD/LD formulations. The most commonly reported adverse events were nausea and anxiety.
Clinical Implications
CREXONT represents a potential paradigm shift in PD management, offering:
- Reduced dosing frequency (three times daily)
- Extended “Good On” time
- Potential for improved patient compliance and quality of life
