- A independent safety board determined at-home use of Cynapsus Therapeutic's under-the-tongue formulation of the Parkinson's disease drug apomorphine is safe, allowing the Canadian company to proceed with its trial of APL-130277.
- Apomorphine is currently the only approved agent for the treatment of 'off' episodes in patients with Parkinson's disease (PD). It is a strong dopamine agonist used to treat the motor fluctuations and movement disorders which commonly occur in patients taking levodopa—the main treatment for patients with PD. PD is a disease characterized by an on/off dynamic for symptoms.
- Cynapsus aims to provide PD patients another administration option for apomorphine by testing sublingual thin film. Apomorphine is currently administered subcutaneously, which is considered the best way to achieve fast results and optimal pharmacokinetics.
Cynapsus hopes to develop another delivery option for the roughly one million people in the U.S. and the 1.2 million people in Europe living with PD, and to open up the convenience of in-home titration. Since safety is a major concern, the data safety monitoring board looked at data from the Phase 3 study of APL-130277. The board focused on what happened when patients titrated the drug in at-home settings, assessing safety at the 12-week mark.
"Allowing the trial to proceed with the modification for at-home titration is expected to make it more convenient for PD patients to treat their off episodes. We believe this change may assist with patient compliance and allow Cynapsus to assess results in a more real-world setting," said Dr. Albert Agro, chief medical officer of Cynapsus.
Once Cynapsus completes CTH-300 and its follow-up study, the company plans to file for regulatory approval during the first half of 2017. If is approved, the drug would give patients with PD a third option for treating "off" symptoms.