Objective/Rationale:
Apomorphine is an under-utilized medication in Parkinson's disease (PD). Despite its strong efficacy as a rescue medication for intermittent "off" episodes in PD and its rapid onset of action, the Apokyn injection of apomorphine can be painful and patients can resist use until the latest stages of PD. Additionally, physicians find the dose initiation cumbersome. Eliminating some of these barriers are key objectives of Cynapsus’ APL-130277, a fast-dissolving, under-the-tongue thin-film product containing apomorphine. This study will compare the pharmacokinetics of APL-130277 compared to Apokyn injection. The goal is to achieve pharmacokinetics that mimic Apokyn injection, without the needle.
Project Description:
This comparative biostudy will measure the pharmacokinetics of APL-130277 as compared to the injectable form of apomorphine, Apokyn. The study is a two-period, placebo-controlled, cross-over design in healthy volunteers (N=30). The first cohort (n=15) will receive a dose of APL-130277 followed by a 24-hour washout and then dosed with 2mg of Apokyn. The second cohort (n=15) will receive a higher dose of APL-130277 followed by a washout and then 4mg of Apokyn. This study will determine dose proportionality for use in the pivotal bioequivalence trial.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
This rescue medication for "off" episodes in PD could offer an alternative to treatment that is easier to self-administer and therefore may be used more often, improving more patients' quality of life.
Anticipated Outcome:
This comparative biostudy will lead directly in to the study of the bioequivalence of APL-130277 with injected apomorphine.
PARTNERING PROGRAM
This grant was selected by The Michael J. Fox Foundation staff to be highlighted via the Foundation’s Partnering Program.
Progress Report
Apomoprhine was given to healthy volunteers in two forms: a needle under the skin (this is the way the drug is given by doctors today) or under the tongue using a thin-film strip (like a Listerine strip). The results showed that the blood concentrations of apomorphine were comparable when either the injection was given or the thin-strip was used under the tongue. Subjects receiving the thin-film strip appeared to have milder side effects than those receiving the injection. The results suggest that giving apomorphine under the tongue using a thin-film strip may be an improved approach to relieving freezing episodes in patients with Parkinson’s disease. Future studies in patients will be started in 2014.
March 2014
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