Accepting the application means the agency is ready to start its regulatory review of the therapy. It expects to decide whether to approve Inbrija by Oct. 5, 2018.
Inbrija is an inhaled powder formulation of levodopa for the times when the effect of Parkinson’s patients’ oral levodopa and carbidopa regimen wears off. Doctors refer to such times as off periods.
Although levodopa is the most effective oral Parkinson’s therapy, many patients experience movement difficulties during off periods, which become more common as the disease progresses.
“Off periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community,” Dr. Burkhard Blank, Acorda’s chief medical officers, said in a press release.
The New Drug Application included results of the 12-week Phase 3 SPAN-PD clinical trial (NCT02240030), which covered 351 patients. It test more than one Inbrija dose.
A key finding was that the higher dose of Inbrija administered up to five times a day improved patients’ movement during off periods, compared with a placebo. The results were in line with those of a Phase 2b trial.
FDA officials initially refused to accept the application for Inbrija — not because of safety or effectiveness concerns, but because of questions about its manufacturing process. Acorda addressed the questions in its resubmitted application.
“People with Parkinson’s and physicians need more options to manage this disease,” said Dr. Todd Sherer, the CEO of The Michael J. Fox Foundation. “Inhaled delivery of levodopa could help the many people living with Parkinson’s facing the complication of off periods as their disease progresses.”
The foundation funded some of the work of the therapy’s original developer, Civitas. Acorda acquired Civitas later.
Acorda uses its ARCUS delivery system to get Inbrija powder into patients’ lungs. From there it travels to the brain.
Oral and nasal-passage-delivered medications are administered through the digestive tract, getting to the brain slower.