Pharmacokinetics and Comparative Bioavailability of Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations in Patients with Parkinson's Disease and "OFF" Episodes: Results of a Randomized, Three-Way Crossover, Open-Label Study.

ABSTRACT:

Introduction

In a pivotal study, apomorphine sublingual film (APL; KYNMOBI^®) was an effective and generally well-tolerated on-demand treatment of "OFF" episodes in patients with Parkinson's disease (PD), approved across the dose range of 10-30 mg. Pharmacokinetics and comparative bioavailability of APL and two subcutaneous (SC) apomorphine formulations (SC-APO [APOKYN^®] and SC-APO-GO [APO-go^® PEN]) were evaluated in a randomized, three-way crossover, open-label study (NCT03292016).

Methods

Patients with PD and "OFF" episodes received an open-label randomized sequence of single doses of SC-APO and SC-APO-GO at the currently prescribed dose (2/3/4/5 mg) and APL doses with similar plasma exposure (15/20/25/30 mg) with ≥ 1-day washout between for

SUBMITTER: Agbo F 

PROVIDER: S-EPMC8571442 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature