Treating Parkinson’s disease with CVT-301 — an investigational, inhaled levodopa — causes no changes in lung function, according to results of two clinical trials led by Acorda Therapeutics of Ardsley, New York.
Acorda is developing CVT-301 to treat “off” episodes in Parkinson’s patients who are taking oral carbidopa/levodopa. The inhaled formulation delivers a precise amount of medication into the lungs, and quickly reaches the brain.
Two studies are currently investigating the drug’s long-term safety. The CVT-301-005 study (NCT02352363) enrolled 271 Parkinson’s patients with no history of asthma or other chronic lung disease, to assess pulmonary function after one year of treatment. These patients received CVT-301 (84 mg) up to five times a day and standard of care. Results were compared to those of 127 patients who received only standard of care (control group).
Researchers saw no difference between the two groups, proving that CVT-301 has no effect on pulmonary function in Parkinson’s patients. In this study, the most common side effects were cough (mild to non-severe), nasopharyngitis (cold), dyskinesia (involuntary movements) and falls.
In the CVT-301-004E study (NCT02242487), 149 patients were given 84 mg of CVT-301 and 146 patients were treated with 60 mg. The study had no control group, and the safety findings were similar to those reported in the CVT-301-005 study.
Acorda plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration later in 2017, and a Marketing Authorization Application (MAA) in Europe by year’s end.
“We are delighted with these results, and plan to move forward with our NDA filing for CVT-301,” Burkhard Blank, MD, Acorda’s chief medical officer, said in a news release. “These two studies, which include approximately 700 participants, represent the largest safety database evaluating long-term pulmonary function in people with Parkinson’s. We thank the study volunteers and clinical investigators, whose willingness to participate in these trials has been essential to the progress of this program.”
Acorda has also conducted other studies to investigate CVT-301’s safety. In a study of people with mild to moderate asthma, 25 individuals received three inhalations of CVT-301, or a placebo, separated by four hours. Ten individuals on CVT-301 developed acute bronchoconstriction, but the symptoms disappeared without further treatments and returned to normal one day later. The most common side effect reported in this study was mild to moderate cough (15 patients).
In another study, 25 smokers without chronic lung disease and 31 healthy non-smokers were given CVT-301 (84 mg). There was no difference in pulmonary function between the two groups. The most common side effect was also mild cough. Finally, in a study of patients with early morning “off” periods, 36 patients with Parkinson’s disease received CVT-301 combined with carbidopa/levodopa during their first off period of the day (early morning) or placebo, to assess CVT-301 safety. Cough was the most frequently observed side effect, and no other safety issues were reported.