The investigational drug is being studied as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms.
The Phase III Span-Pd trial enrolled 339 patients with Parkinson’s disease and found that 84 milligrams of CVT-301 improved motor function compared to placebo, measured at 30 minutes post-dose after 12 weeks.
The Ardsley, N.Y.-based company said the trial’s results were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Vancouver, British Columbia.
The most commonly reported adverse events in the CVT-301 group were cough, upper respiratory tract infection, nausea, sputum discoloration and dyskinesia. Two of the 114 patients that were treated with CVT-301 withdrew from the study due to a cough.
Acorda also touted interim data from an ongoing long-term safety study. The primary objective of the 52-week study is to evaluate pulmonary function by measuring forced expiratory volume in 1 second and diffusing capacity of the lung for carbon monoxide.
There were no statistical differences in the mean changes of either measure from baseline until week 52 between the CVT-301 group and the control group.
Seventeen patients in this trial suffered fractures, but they were judged be unlikely or not related to CVT-301. Three of the 271 patients receiving CVT-301 had to stop participating due to a cough.
There was also 1 death in the trial, but the researchers determined it was not related to Acorda’s drug.
The trial included several exploratory efficacy measurements that were only assessed in the CVT-301 branch. At 52 weeks, 85% of patients maintained an “on” state 60 minutes post-dose and 73% of patients reported motor improvements.
Over the course of the study, the average patient used 2.3 doses of CVT-301 each day.
The company said it plans to file a new drug application for its inhaled Parkinson’s drug with the FDA by the end of the 2nd quarter of this year, as well as a marketing authorization application with the EMA by the end of 2017.
ACOR shares were trading at $16.60 apiece in early-morning activity, up 8.5%.