Amneal has commenced a Phase III trial evaluating the safety and efficacy of IPX203 against immediate-release (IR) carbidopa-levodopa (CD-LD) for the treatment of patients with advanced Parkinson's disease (PD).
The active-controlled, parallel group trial expects to enrol around 500 patients.
The Phase III clinical development plan also includes a 13-week efficacy and safety study followed by a nine-month safety extension study.
Amneal president and CEO Robert Stewart said: “The results from the Phase IIb study provide supporting data on the safety and efficacy profile of the investigational drug, IPX203, and underscore the importance of continuing its evaluation in patients with Parkinson's disease.”
The company also noted that the findings from the multiple-dose Phase IIb study conducted in 28 patients with advanced PD confirmed previous results from a Phase IIa single dose study.
The Phase IIb study reported treatment-emergent adverse events (TEAEs) including nausea, dizziness, and dyskinesia in two or more subjects.
PD is a long-term degenerative disorder of the central nervous system that primarily affects the motor system.
University of South Florida professor and Parkinson's Disease and Movement Disorders Center director Dr Robert Hauser said: “As Parkinson's disease progresses, patients develop motor fluctuations such that the improvement from a dose of standard levodopa formulations, called ‘On’, lasts a shorter time and then symptoms return.
“IPX203 demonstrated a significant increase in the duration of ‘On’ time in both single and multiple dose studies.”
IPX203 is an investigational extended-release oral capsule formulation of CD-LD, and is currently being studied as a potential treatment for the symptoms of advanced PD.