Today, Acorda Therapeutics announced positive results from the Phase III trial of CVT-301, an inhalable form of levodopa. MJFF funded earlier work on this drug by biotech Civitas before it was acquired by Acorda.
The new formulation of levodopa is being studied as a treatment for "off" periods -- times when Parkinson's symptoms are not controlled -- in people with Parkinson's who are taking oral carbidopa/levodopa. In the Phase III trial, people with Parkinson's who experienced "off" time had greater improvement in their motor symptoms when they were treated with the study drug compared to those who took the placebo. The trial also demonstrated the drug was safe.
"Off" times, especially when sudden and unexpected, can significantly impact a person's quality of life. Todd Sherer, PhD, CEO of MJFF says, "This potential new treatment for the management of re-emergent symptoms will address an unmet need for many patients and families."
CVT-301 will now complete long-term safety testing in two other ongoing studies. Based on that information, Acorda plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) later this year.