Acorda Therapeutics, Inc. recently presented the results of its Phase 2b study of CVT-301, an inhaled levodopa (L-dopa) under development for patients with OFF episodes associated with Parkinson’s disease (PD).
OFF episodes cause the re-emergence of PD motor symptoms, including muscle stiffness, impaired movement and tremor. Results from the study showed that patients on an OFF episode who received CVT-301 had significant improvements in their motor function when compared to patients who received an inhaled placebo; the effect was seen 10 minutes after patients received the drug and lasted for at least an hour. Results were presented during the 19th International Congress of the Parkinson’s Disease and Movement Disorders (MDS), which took place in San Diego, California.
“Oral levodopa, or L-dopa, is the current gold standard of care for Parkinson’s disease. However, as the disease progresses, the majority of people will experience OFF episodes, even while on L-dopa therapy,” said in a recent press release Enrique Carrazana, M.D., Chief Medical Officer of Acorda. “Based on the successful results of this study, we have initiated a Phase 3 clinical and a long-term safety trial to further assess the potential of CVT-301 to reduce the duration of OFF episodes in people taking oral L-dopa. We believe that if successful, these results, together with the existing Phase 2b data, will enable Acorda to file a New Drug Application with the FDA.”
The clinical trial was a Phase 2b multi-center, double blind, randomized, placebo-controlled study in which 86 PD patients were enrolled to receive treatment for their OFF episodes. Patients were randomized to receive CVT-301 or a placebo, as a complement of their oral PD medications.
Patients who received CVT-301 had a significant reduction in their UPDRS III (Unified Parkinson’s Disease Rating Scale Part 3) mean score, when compared to those who received the placebo. Furthermore, all patients tolerated CVT-301 doses with no major serious adverse events.
“OFF episodes have a major negative impact on the lives of people with Parkinson’s disease, as well as on their loved ones and care partners. Effective treatment options are desperately needed,” said Robert Hauser, M.D., Professor of Neurology, Molecular Pharmacology and Physiology at the University of South Florida and one of the authors of the poster. “The study results reported today indicate that patients treated with CVT-301 had rapid, clinically meaningful improvements in motor function. This suggests CVT-301 has the potential to be an exciting new therapy to treat OFF episodes in people with Parkinson’s. I am looking forward to the results of the ongoing clinical studies, which are designed to provide confirmatory information about the safety and efficacy of CVT-301 in treating OFF episodes.”