Sunovion Pharmaceuticals Inc. said the U.S. Food and Drug Administration has accepted the resubmitted marketing application for its apomorphine film that is placed under the tongue to treat motor fluctuations in patients with Parkinson's disease.
The Marlborough, Mass.-based private pharmaceutical company in November resubmitted the new drug application for APL-130277, which treats the re-emergence or worsening of Parkinson's symptoms between medication dosages. About 40% to 60% of patients with Parkinson's disease experience these so-called off periods, resulting in tremors, stiffness or slow movement.
The U.S. regulator rejected an earlier application by Sunovion in January and issued a complete response letter requesting the company provide additional data. The FDA did not ask the company to conduct new clinical trials.
The FDA is set to decide on the newly accepted application by May 21, 2020.
APL-130277 was originally developed by Cynapsus Therapeutics Inc., which was acquired by Sunovion in October 2016.
Sunovion is an indirect, wholly owned subsidiary of Japanese pharmaceutical company Sumitomo Dainippon Pharma Co. Ltd.