Michael J. Fox powerfully describes the challenges associated with the variability of his medication in a recent NPR Interview.
Over one million people in the US and between seven and ten million people worldwide suffer from Parkinson’s disease. Parkinson’s disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine and is characterized by symptoms including tremors at rest, rigidity and impaired movement. The standard of care for the treatment of Parkinson’s disease symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream leading to the unreliable control of symptoms resulting in the emergence of OFF episodes. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of Parkinson’s disease patients and are considered one of the greatest unmet medical needs facing Parkinson’s disease patients today.
CVT-301 is being developed as a self-administered, adjunctive, as needed, inhaled L-dopa therapy for OFF episodes, providing rapid delivery of L-dopa to the brain to be used in conjunction with a Parkinson’s disease patient’s individually optimized oral L-dopa regimen. CVT-301 leverages Civitas’ proprietary ARCUS®
technology which enables the delivery of a precise dose to the lung to potentially enable rapid and predictable L-dopa absorption through a reusable, pocket-size, breath-actuated inhaler. We have completed a Phase 2b clinical trial for CVT-301 demonstrating the ability to rapidly and predictably treat OFF episodes as they occur.
CVT-301 clinical studies conducted to date have been funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.