Acorda announced favorable results in a phase 3 trial of inhalable levodopa.
Acorda Therapeutics announced positive results from phase 3 trials of an experimental drug product it calls CVT-301. A formulation of levodopa that can be inhaled, the product is meant to treat re-emergence of symptoms in patients with Parkinson's disease who are on an oral carbidopa/levodopa regimen.
In a trial known as SPAN-PD, 339 patients were grouped into three arms. One group got a dose of 84mg, one got 60mg, and the other got a placebo.
The primary endpoint was the change in scores on the Unified Parkinson's Disease Rating Scale-Part 3 at 12 weeks.
The scale measures motor impairment. The company said the patients getting CVT-301 had better results compared to placebo.
The patients getting the higher dose saw their impairment scores drop by 9.83 points compared to a drop of 5.91 points for those on the placebo, a statistically significant difference, the company said.
Inhaled levodopa should be better than oral, the company said, because "oral medication can be associated with slow and variable onset of action as the medicine is absorbed through the digestive tract before reaching the brain." Inhaled medications get to the brain more quickly.
Detailed results are due to be presented at a medical meeting, which the company did not name.
Acorda said it plans to file a new drug application with the US Food and Drug Administration (FDA), based on the trial results.