Acorda plans NDA for inhaled Parkinson’s drug after touting long-term safety data

Acorda Therapeutics (NSDQ:ACOR) touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving CVT-301, the inhaled formulation of Parkinson’s drug levodopa, and the control group.

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 Ardsley, N.Y.-based company said the 12-month safety results are consistent with data from Phase IIb and III clinical evaluations.

Acorda plans to submit a New Drug Application to the FDA by the end of the 2nd quarter of 2017, as well as a Marketing Authorization Application in Europe by the end of this year.

“We are delighted with these results, and plan to move forward with our NDA filing for CVT-301. These 2 studies, which include approximately 700 participants, represent the largest safety database evaluating long-term pulmonary function in people with Parkinson’s,” chief medical officer Dr. Burkhard Blank said in prepared remarks. “We thank the study volunteers and clinical investigators, whose willingness to participate in these trials has been essential to the progress of this program.”

One of the company’s 12-month studies enrolled 271 Parkinson’s patients who do not have a history of asthma or other chronic lung disease. These patients received CVT-301 up to 5 times a day, as well as the usual standard of care. The company is tracking this group’s progress compared to an observational control group composed of 127 Parkinson’s patients who are managed with just standard of care.

In the 2nd long-term trial, 149 patients received 84 mg of CVT-301 and 146 patients received 60 mg of the drug. There is no control arm in the study, according to Acorda.

The primary objective of the analyses is to measure lung function.

In February, the company said that the Phase III clinical trial evaluating CVT-301 met its primary endpoint.