The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling.
The FDA’s refusal to file letter had to do with the date that a manufacturing site would be ready for inspection and raised questions about the drug master production record. The company’s resubmitted application addresses the two problems outlined in the agency’s RTF, Acorda said.
The FDA is expected to let Acorda know within 74 days if the resubmitted NDA is complete enough for a full review.
Acorda’s Inbrija is being developed as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms.
In March, the company touted data from two ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving the inhaled formulation of Parkinson’s drug levodopa and a control group.