Report from the 1st Congress of the European Academy of Neurology, Berlin, Germany, June 20-23, 2015 – Subcutaneous apomorphine is clinically available in many countries for the acute treatment of Off periods in PD. Alternative delivery methods have been investigated for several decades.
A new sublingual formulation, APL-130277, by a Canadian drugmaker has now completed early open-label phase IIa testing and results are available (Hauser et al. EAN 2015; abstract P2153).
The open-label study enrolled 19 advanced PD patients with motor fluctuations and a mean of 3.9 Off episodes per day. Mean age was 61 years; and mean levodopa dose was 836.8 mg/day. Subjects were evaluated in the pre-dose morning Off state and at 15, 30, 45, 60 and 90 minutes after administration of sublingual apomorphine. Overall, 15 of 19 patients achieved an On response after drug administration. The mean change from baseline in MDS-UPDRS Part III score was -15 at 45 minutes (-35%), and -9 at 90 minutes (-24%). A majority of subjects responded to the lowest doses (10-15 mg). The most common adverse effects were dizziness (36.8%), somnolence (31.6%), nausea (21.1%) and yawning (15.8%) (Isaacson et al. EAN 2015; abstract P215). There were two serious adverse events (somnolence, dysphagia). Most adverse events were mild.
The phase III CTH-300 trial (NCT02469090) enrolled its first patient in June 2015. Planned enrollment is 126 PD patients with at least one Off period every 24 hours. Thirty-five study centres are expected to participate. The primary endpoint of the 12-week study will be the mean change in MDS-UPDRS Part III score at 30 minutes after dosing.
Reviewer: Dr. Susan Fox