AUGUST 29, 2016
Company provides timing updates
TORONTO, Aug. 29, 2016 (GLOBE NEWSWIRE) — Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).
“The FDA’s recognition of the significant need to address OFF episodes in Parkinson’s disease with the Fast Track Designation is further validation of the value in our fast-acting, thin strip approach,” said Anthony Giovinazzo, President and CEO of Cynapsus. “We look forward to continuing to work with the FDA to advance APL-130277 through the regulatory process to bring relief to patients suffering with OFF episodes as expeditiously as possible. Our Phase 3 clinical program is nearing completion and we plan to submit a new drug application (NDA) to the FDA in the first half of 2017.”