Drug Overview
APL-130277 (Dainippon Sumitomo/Sunovion) is a sublingual film formulation of apomorphine, a non-ergoline dopamine receptor agonist. It is being developed for the on-demand treatment of “off” periods in late-stage Parkinson’s disease. In the more advanced stages of Parkinson’s disease with prolonged levodopa use, patients begin experiencing fluctuations in levodopa levels; these can result in peak-dose dyskinesia, and in “off” periods, where patients display muscle rigidity, tremor, and bradykinesia. APL-130277’s sublingual route of administration should allow for apomorphine’s fast onset of action, and help to quickly convert a patient in an “off” state to an “on” state.
Sumitomo Dainippon, via its US subsidiary Sunovion, is responsible for the development and marketing of APL-130277 following its 2016 acquisition of Cynapsus Therapeutics, the drug’s originator. The new Drug Application for APL-130277 was submitted in March 2018, and while Sumitomo Dainippon has previously mentioned plans to pursue development in Europe and Japan, the company’s pipeline only lists APL-130277 as being developed in the US at present.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 APL-130277 : Parkinson’s disease
LIST OF FIGURES
8 Figure 1: APL-130277 for Parkinson’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of APL-130277 for Parkinson’s disease
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of APL-130277 for Parkinson’s disease
12 Figure 4: APL-130277 sales for Parkinson’s disease in the US, 2016–25
LIST OF TABLES
6 Table 1: APL-130277 drug profile
7 Table 2: APL-130277 Phase III data in Parkinson’s disease
12 Table 3: APL-130277 sales for Parkinson’s disease in the US ($m), 2016–25