The study seeks to characterize the pharmacokinetic profile of ropinirole delivered continuously.
Titan Pharmaceuticals treated its first patient this month using the company’s ProNeuraTM continuous delivery implant to administer ropinirole, a drug prescribed to treat the signs and symptoms of idiopathic Parkinson’s disease.
A dopamine agonist, ropinirole is an orally dosed formulation for treating Parkinson’s and restless leg syndrome. It is often used in parallel with L-dopa to suppress serious motor control complications from its long-term use. The implant, developed using Titan’s proprietary ProNeura drug delivery system, is designed to continuously deliver ropinirole HCL over long periods.
The ropinirole trial is an open-label, sequential, dose calculation study. Twenty patients will be enrolled to assess the drug, with an emphasis on pharmacokinetic profile. Patients will be put on a stable dose of L-dopa and an oral dose of ropinirole, but will have their oral ropinirole replaced with the ropinirole implant for three months of treatment. Initial data from the first cohort of patients is expected by the first quarter of 2018; study completion is targeted for the end of that year.
Kate Beebe, Titan's Executive Vice President and Chief Development Officer noted: "We are pleased to begin treating the first patient in this important study to evaluate the pharmacokinetic profile, safety and tolerability of our ropinirole implant, which is designed to deliver continuous, non-fluctuating levels of this dopamine agonist for up to three months. We believe our ropinirole implant has the potential to offer patients substantial benefits over existing daily and more frequently dosed oral formulations of ropinirole, and we look forward to continuing to enroll subjects in this study."