Kyowa drug produces varied results in Parkinson’s

Three phase III clinical studies were conducted in Parkinson’s patients who had developed a shortened response to treatments, called the ‘wearing off phenomenon.’ To assess the drug’s impact, measurements were taken of the amount of time patients spent in ‘off periods,’ when the drugs are partially or completely ineffective.

One North American study revealed a statistically significant reduction in the percentage of awake time spent in the ‘off’ state – the primary endpoint of the trial.

However, another North American study and a trial conducted in the EU/other regions did not demonstrate a significant reduction in percentage of awake time per day spent in the ‘off’ state compared with placebo-treated patients.

On the other hand, this trial did show a significant improvement or a trend toward improvement in one of the secondary endpoints, the motor function score, assessed using the Unified Parkinson’s Disease Rating Scale.

Parkinson’s disease is initiated by a shortage of the neurotransmitter dopamine in the brain, which causes an imbalance in the nervous system. This disease is treated mainly by dopamine replacement with L-DOPA. Long-term therapy with L-DOPA is associated with the development of a shortening response to each dose.

Despite the varied results, the company said that it plans to submit a new drug application to the FDA in the latter half of this year.