A sublingually delivered thin film strip to treat advanced Parkinson's disease kicked off its Phase II clinical trial following discussions with the FDA, Cynapsus Therapeutics announced July 16.
If all goes as planned on the regulatory front, the candidate, dubbed APL-130277, will become the first noninjectable apomorphine therapy to treat debilitating "off" episodes of the disease, which render the patient immobile. Cynapsus said it expects to file a New Drug Application with the FDA for the reformulated version of apomorphine in 2016.
During the Phase II trial, 16 Parkinson's patients who have not received apomorphine previously and suffer from daily "off" episodes for at least two hours a day will receive the medication. The trial will study the effect of the medication over a single day and will be used to gather information about dose strength for a larger efficacy trial expected to start in Q4 2014.
The larger trial will be double-blind and placebo-controlled, Cynapsus said. Its primary endpoint will be the change in part III of the Unified Parkinson's Disease Rating Scale score. Part III involves a motor examination of movements such as rotation of the hands and forearms, according to the European Parkinson's Disease Association.
Injectable apomorphine is marketed as Apokyn in the U.S. by Britannia Pharmaceuticals. Apomorphine is used as an as-needed "rescue" supplement to the mainline Parkinson's treatment levodopa, which typically diminishes in effectiveness after 5 years of use.
"Off' episodes begin when the levodopa or enzyme inhibitors enter the bloodstream too slowly, or wear off quickly, or just do not enter the bloodstream sufficiently at all," Cynapsus Chief Medical Officer Dr. Albert Agro explained in a previous interview with FierceDrugDelivery. He said that 85% of Apokyn patients have an injection-site reaction due to apomorphine's acidity and must continuously change the injection site. APL-130277 contains a buffer that protects the patient from the acidic properties of the medication, he added.
Another advantage of APL-130277 is ease of use, Agro said, pointing out that delivering an injection prior to the onset of an "off" episode can be a challenge for Parkinson's patients.
Cynapsus says that more than 1 million people in the U.S. and an estimated 4 million to 6 million people worldwide have Parkinson's disease. It is an active disease area for drug delivery research. In April, Civitas Therapeutics said that its inhaled levodopa formulation, CVT-301, met its primary endpoint in a Phase II study.
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