Therapy Areas: Central Nervous System
Sunovion resubmits Apomorphine Sublingual Film NDA with FDA for treating Parkinson's disease motor fluctuations
23 December 2019 -

Biopharmaceutical company Sunovion Pharmaceuticals Inc said on Friday that it has filed its New Drug Application (NDA) for apomorphine sublingual film with the US Food and Drug Administration (FDA) for treating motor fluctuations in Parkinson's disease (PD).

The company said the US FDA filing for apomorphine sublingual film (APL-130277) was resubmitted on 21 November 2019 and the expected action date under the Prescription Drug User Fee Act (PDUFA) is 21 May 2020.

Apomorphine sublingual film, a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting on-demand treatment of motor fluctuations (OFF episodes) associated with Parkinson's disease (PD). It is designed to offer a potential option that may be used to treat OFF episodes associated with PD up to five times throughout the day. PD is a chronic, progressive neurodegenerative disease characterized by tremor, rigidity, impaired movement, non-motor symptoms, cognitive impairment and mood disorders.

Additionally, the results of the company's pivotal Phase 3 study (CTH-300) of apomorphine sublingual film were recently published in Lancet Neurology. Apomorphine sublingual film and has not been approved by the US Food and Drug Administration (FDA).

In October 2016, Sunovion acquired Cynapsus Therapeutics Inc (Canadian Specialty Central Nervous System Biotechnology Company), along with its product candidate APL-130277. Two early-stage APL-130277 trials were funded in part by The Michael J. Fox Foundation.