Sunovion Pharmaceuticals Inc issued the following announcement on June 12.
Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 29, 2019.
“Through our ongoing work with people living with Parkinson’s disease, we know the community is eager for more treatment options that may help alleviate OFF episodes, which are often disruptive to their daily lives,” said Todd Sherer, Ph.D., CEO of The Michael J. Fox Foundation for Parkinson’s Research. “We’re heartened to see apomorphine sublingual film is successfully continuing through the regulatory process, and we are hopeful for its approval and future availability.” Two early-stage APL-130277 trials were funded in part by The Michael J. Fox Foundation.
Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. Motor OFF episodes can cause severe disruption for someone living with PD, often causing a major disturbance in a person’s ability to maintain everyday activities. While OFF episodes are experienced by 40 to 60 percent of all people living with PD there are limited on-demand treatment options available.1
“We are encouraged that the FDA has accepted our NDA for apomorphine sublingual film,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “There are currently few treatment options available to Parkinson’s disease patients for the as needed treatment of OFF episodes. We look forward to working with the FDA during the review period so that we can bring a much needed new treatment option to people living with Parkinson’s disease and OFF episodes.”
Original source can be found here.
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