- The FDA designates Cynapsus Therapeutics' (CYNA +0.5%) Phase 3-stage AL-130277 for Fast Track review for the treatment of OFF episodes in patients with Parkinson's disease (PD).
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- An OFF episode, a time during which PD patients are unable to perform routine activities like eating, bathing or dressing, is thought to occur when dopamine levels in the brain fall below a certain threshold. It is considered one of the greatest unmet medical needs of PD sufferers.
- APL-130277 is a sublingual (under the tongue) formulation of apomorphine.