Acorda Therapeutics (NSDQ:ACOR) said today that the FDA accepted the New Drug Application for its Inbrija investigational inhaled levodopa product designed for treating symptoms of OFF periods in patients with Parkinson’s disease who are taking carbidopa/levodopa regimens.
The approval comes with a target date of October 5, 2018, the Ardsley, N.Y.-based company said.
The NDA comes supported by data from the company’s Phase 3 safety and efficacy study and from two long-term safety studies of patients with Parkinson’s disease. Results from these studies were presented at the International Congress of Parkinson’s Disease and Movement Disorders last June.
“OFF periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community. We are excited about the potential to bring this highly innovative treatment option to people living with Parkinson’s, and look forward to working with the FDA throughout the review process,” Acorda chief medical officer Dr. Burkhard Blank said in a prepared statement.
The phase I and II studies of Inbrija were funded in part by grants from the Michael J. Fox Foundation for Parkinson’s Research, Acorda said.
“People with Parkinson’s and physicians need more options to manage this disease. Inhaled delivery of levodopa could help the many people living with Parkinson’s facing the complication of OFF periods as their disease progresses,” Michael J. Fox Foundation CEO Todd Sherer said in a press release.
Earlier this month, Acorda saw shares fall after the biotech company met sales expectations on Wall Street with its fourth-quarter results, but missed EPS estimates.