Cynapsus Receives FDA Fast Track Designation For APL-130277

(RTTNews) - Cynapsus Therapeutics Inc. (CYNA, CTH.TO) said that the U.S. Food and Drug Administration or FDA has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson's disease or PD.

"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," said Anthony Giovinazzo, President and CEO of Cynapsus.

Cynapsus provided timing updates for two clinical trials. Based on patient visit schedules, post the dose titration phase, top line data for the Phase 3 Efficacy trial CTH-300 is expected in mid-to-late fourth quarter of 2016. The CTH-201 Phase 2 Thorough QT study, is expected to commence in the fourth quarter of 2016, and is planned to be completed in the first half of 2017.