Investigational Treatment for Reduction of OFF Time in Parkinson’s Disease

Tozadenant is being investigated to reduce OFF time in people with Parkinson’s who are taking a carbidopa/levodopa regimen. Biotie Therapies (our subsidiary acquired in 2016) is currently conducting a Phase 3 clinical trial, in which tozadenant is taken along with a person’s other Parkinson’s therapies. The study is assessing improvement of motor function and activities of daily living in people with Parkinson’s while taking tozadenant.

You can learn more about the trial, including how to participate, here. The study, which is being conducted under a Special Protocol Assessment from the U.S. Food & Drug Administration (FDA), is anticipated to be completed by the end of 2017. A separate open-label safety study is expected to begin enrollment in the first half of 2017.

There are approximately one million people in the U.S. and 1.2 million Europeans diagnosed with Parkinson’s. It is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. Treatment regimens generally include oral carbidopa/levodopa, recognized as the cornerstone of Parkinson’s therapy. Over time, many people with Parkinson’s will experience periods during which their symptoms re-emerge, despite being on therapy. This return of symptoms is known as OFF. Approximately 50% of people using oral carbidopa/levodopa will experience OFF within five years of initiating treatment. As the disease progresses, the frequency and severity of OFF may increase. OFF can be very disruptive to the lives of people with Parkinson’s and their families.

An orally-administered selective inhibitor of the adenosine 2a (A2a) receptor, it is hypothesized that tozadenant may restore motor function in people with Parkinson’s who experience OFF without the induction of troublesome dyskinesias, a distortion of voluntary movement that is a common side effect of current Parkinson’s regimens. If successful, tozadenant could represent the first new class of drug approved in the United States for improvement of motor symptoms in Parkinson’s in more than 20 years.

The Acorda group of companies currently has two Parkinson’s programs addressing motor fluctuations: tozadenant is being studied as a twice-daily pill taken to reduce the amount of time a person spends in an OFF state; CVT-301 is an investigational, self-administered, inhaled version of levodopa (L-dopa) for the treatment of OFF periods when they occur as an adjunct to an oral carbidopa/levodopa regimen to return a person to an ON state.