Cynapsus Therapeutics Nabs FDA Fast Track for Parkinson’s Disease Candidate

The FDA granted a fast track designation to APL-130277 for the treatment of “off” episodes in patients with Parkinson’s disease.

APL-130277 is a formulation of apomorphine given sublingually, as a thin film strip. Currently, apomorphine is only approved by FDA as a sterile subcutaneous injection.

Off episodes occur when a maintenance treatment dose wears off and symptoms are no longer controlled, resulting in tremors, decreased mobility, and other symptoms.

The drug’s sponsor, Cynapsus Therapeutics, plans to submit an NDA in the first half of 2017.